AzTrials
AzTrials

Locally Advanced Unresectable Pancreatic Ductal AdenocarcinomaPhase 3LAP100NCT06958328

Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer

A Phase 3 study testing Biopsy Procedure, Biospecimen Collection and Capecitabine in people with Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma and Stage II Pancreatic Cancer AJCC v8, run by NRG Oncology at 333 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-8 months of chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy Procedure, Biospecimen Collection and Capecitabine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
356 participants
Where
333 sitesin 2 countries
Study dates
21 Aug 2025to 21 Oct 2030
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At time of enrollment, the patient must have received 4-8 months of active chemotherapy with FOLFIRINOX or NALIRIFOX or gemcitabine/nab-paclitaxel. Patients are permitted to receive more than 1 type of chemotherapy for reasons other than radiographic progression by Response Evaluation Criteria in Solid Tumors (RECIST) (i.e. chemotherapy regimen switch is allowed for toxicity, and/or switch is allowed for toxicity and/or CA19-9 level not declining). Patients are allowed to receive chemotherapy after restaging scans, as long as 1) restaging scans are performed after at least 4 months of chemotherapy and 2) the total chemotherapy duration does not exceed 8 months
  • "Active chemotherapy" refers to time on chemotherapy not counting treatment breaks (i.e. if a patient had 1 month of chemotherapy followed by 1 month break, this would count as 1 month chemotherapy). Study registration must occur within 45 days of last day of pre-study entry chemotherapy
  • BASELINE PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:
  • Pathologically (histologically or cytologically) proven diagnosis of pancreatic ductal adenocarcinoma
  • Locally advanced unresectable disease (as defined per the National Comprehensive Cancer Network [NCCN] guidelines and institutional tumor board review)
  • Patients must have baseline pre-chemotherapy scans for staging. Options include: CT chest/abdomen/pelvis, CT chest/MRI abdomen/pelvis, CT chest/CT pelvis/MRI abdomen, or PET/CT performed prior to enrollment
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  • Age ≥ 18 years
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
  • Required initial laboratory values:
  • All laboratory values must be obtained any time prior to initiation of chemotherapy up to 30 days post initiation of chemotherapy
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
  • BASELINE CA19-9 AND BILIRUBIN REQUIREMENTS: The purpose is to obtain a baseline CA19-9 in the setting of a normal (or close to normal) bilirubin, since serologic response by serial CA19-9 measurements is part of post-chemotherapy eligibility criteria
  • If baseline CA19-9 > 37 U/mL the concurrent bilirubin must be ≤ 1.5 x ULN. (Note: if the bilirubin is not ≤ 1.5 x ULN both the CA19-9 and concurrent bilirubin can be repeated until bilirubin is ≤ 1.5 x ULN, as long as done within specified timeframe [up to 30 days post chemotherapy initiation])
  • If baseline CA19-9 U/mL ≤ 37, there are no restrictions on the required concurrent bilirubin level, and this can be the accepted baseline value
  • Prior radiation treatment
  • Has the patient had prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Prior non-overlapping radiation (e.g., breast, head and neck, extremity) is permitted
  • If uncertain about prior overlap, please contact the study principal investigator, Dr. Nina Sanford
  • POST PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:
  • If baseline CA19-9 is elevated (defined as > 37 u/mL) the post-pre-entry chemotherapy CA19-9 must be less than 200 u/mL OR a 70% decline from pre-chemotherapy level (i.e. a patient with post induction chemotherapy CA199 value ≥ 200 u/mL would qualify, as long as they had at least 70% drop from baseline CA199 value; similarly, a patient with less than a 70% decline would qualify as long as absolute value post induction chemotherapy is under 200 u/mL) (must be completed any time post month 4 of chemotherapy and prior to study entry)
  • If baseline CA19-9 is not elevated (defined as ≤ 37 u/mL) the post-pre-entry chemotherapy CA19-9 must remain ≤ 37 u/mL (must be completed any time post month 4 of chemotherapy and prior to study entry)
  • No active duodenal or gastric ulcers
  • No direct tumor invasion of the bowel or stomach
  • Restaging scans showing at least stable disease (no progression). Options for scans include: CT chest/abdomen/pelvis, CT chest/MRI abdomen/pelvis, or CT chest/CT pelvis/MRI abdomen, or PET/CT performed prior to enrollment, with restaging CT showing at least stable disease
  • Not pregnant and not nursing
  • No cardiac condition that was the primary reason for hospitalization in the last 6 months
  • New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

Who cannot join

None listed.

Trial locations and contacts

333 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

301 sites in 2 countries

United States300 sites, 295 recruiting

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-539-2273, info@hawaiicancercare.com

    Jared Hara

    Recruiting

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-486-6000

    Jared Hara

    Recruiting

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-487-7447

    Jared Hara

    Recruiting

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

    Suspended

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706

    Site Public Contact, rohta@queens.org

    Jared Hara

    Recruiting

  • Inova Alexandria Hospital

    Alexandria, Virginia, 22304

    Site Public Contact, 703-776-2580, Stephanie.VanBebber@inova.org

    Tobias R. Chapman

    Recruiting

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    Kyle C. Cuneo

    Recruiting

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, Wisconsin, 54409

    Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org

    Andrew J. Huang

    Recruiting

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Site Public Contact, 404-778-1868

    Pretesh R. Patel

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Pretesh R. Patel

    Recruiting

  • Piedmont Hospital

    Atlanta, Georgia, 30309

    Site Public Contact, 404-425-7943, ORS@piedmont.org

    Eyal Meiri

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Pretesh R. Patel

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    Pretesh R. Patel

    Recruiting

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

    Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu

    Daniel H. Barnett

    Recruiting

  • Advocate Outpatient Center - Aurora

    Aurora, Illinois, 60506

    Site Public Contact, ncorp@aah.org

    Thomas J. Saphner

    Recruiting

  • AIS Cancer Center at San Joaquin Community Hospital

    Bakersfield, California, 93301

    Site Public Contact, 661-323-4673

    Luis Mariscal

    Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

    Site Public Contact, 410-601-9083

    David J. Perry

    Recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Site Public Contact, 212-639-7592

    Marsha Reyngold

    Recruiting

  • MaineHealth Coastal Cancer Treatment Center

    Bath, Maine, 04530

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Matthew D. Cheney

    Recruiting

  • Houston Methodist San Jacinto Hospital

    Baytown, Texas, 77521

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Kevin T. Tran

    Recruiting

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

    Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

    Active, not recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

    Site Public Contact, 800-865-1125

    Kyle C. Cuneo

    Recruiting

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

    Site Public Contact, 718-780-3677, Adg9003@nyp.org

    Raymond M. Luke

    Recruiting

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Parag J. Parikh

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Site Public Contact, 800-767-9355, askroswell@roswellpark.org

    Nadia K. Malik

    Recruiting

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

    Site Public Contact, 856-325-6757

    Gary Eastwick

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Aultman Health Foundation

    Canton, Ohio, 44710

    Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com

    Daniel C. Sufficool

    Recruiting

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Theodore K. Yanagihara

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Brian E. Lally

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Jefferson Cherry Hill Hospital

    Cherry Hill, New Jersey, 08002

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Joseph M. Caster

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    John P. Hayes

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    Mark C. Korpics

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Site Public Contact, 773-296-5360

    Thomas J. Saphner

    Recruiting

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

    Site Public Contact, 513-584-7698, cancer@uchealth.com

    Jordan Kharofa

    Recruiting

  • Morton Plant Hospital

    Clearwater, Florida, 33756

    Site Public Contact, 855-314-8646

    Bansi Savla

    Recruiting

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Parag J. Parikh

    Recruiting

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Shelby Lane

    Recruiting

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

    Site Public Contact, 719-365-2406

    Jeffrey R. Olsen

    Recruiting

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

    Site Public Contact, 719-364-6700

    Jeffrey R. Olsen

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Shelby Lane

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Russell F. Palm

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Site Public Contact, 212-639-7592

    Marsha Reyngold

    Recruiting

  • UT MD Anderson - The Woodlands

    Conroe, Texas, 77384

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Ethan B. Ludmir

    Recruiting

  • Northwest Cancer Center - Crown Point

    Crown Point, Indiana, 46307

    Site Public Contact, 219-836-6879, CancerResearch@powershealth.org

    Daniel H. Barnett

    Recruiting

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

    Site Public Contact, 630-929-6129, advocateresearch@advocate.com

    Thomas J. Saphner

    Recruiting

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Houston Methodist Cypress Hospital

    Cypress, Texas, 77429

    Site Public Contact, 346-356-1413, irb@houstonmethodist.org

    Kevin T. Tran

    Recruiting

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

    Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu

    Todd A. Aguilera

    Recruiting

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237

    Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu

    Todd A. Aguilera

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Todd A. Aguilera

    Recruiting

  • Danbury Hospital

    Danbury, Connecticut, 06810

    Site Public Contact, 833-223-4732

    Seema C. Sanghavi

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Daniel H. Barnett

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu

    Austin J. Iovoli

    Recruiting

  • Miami Valley Hospital

    Dayton, Ohio, 45409

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

    Site Public Contact, 937-276-8320

    Tarek M. Sabagh

    Recruiting

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan, 48126

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Parag J. Parikh

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    John P. Hayes

    Recruiting

  • AdventHealth Porter

    Denver, Colorado, 80210

    Site Public Contact, research.institute@adventhealth.com

    Matthew B. Spraker

    Recruiting

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Kevin L. Du

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Parag J. Parikh

    Recruiting

  • Geisinger Cancer Center Dickson City

    Dickson City, Pennsylvania, 18519

    Site Public Contact, 877-204-6081, cancerresearch@geisinger.edu

    Austin J. Iovoli

    Recruiting

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

    Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com

    Thomas J. Saphner

    Recruiting

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shireen Parsai

    Recruiting

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

    Site Public Contact, 219-924-8178

    Daniel H. Barnett

    Recruiting

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Bevan Ly

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Daniel H. Barnett

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

    Site Public Contact, 847-429-2907

    Thomas J. Saphner

    Recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

    Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org

    Tobias R. Chapman

    Recruiting

  • Inova Fair Oaks Hospital

    Fairfax, Virginia, 22033

    Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org

    Tobias R. Chapman

    Recruiting

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Kevin L. Du

    Recruiting

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

    Site Public Contact, 703-208-6650, Stephanie.VanBebber@inova.org

    Tobias R. Chapman

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

    Site Public Contact, 352-273-8010

    Ibrahim Nassour

    Recruiting

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    John P. Hayes

    Recruiting

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Site Public Contact, 602-747-9738

    Gary V. Walker

    Recruiting

  • Arizona Center for Cancer Care - Gilbert

    Gilbert, Arizona, 85297

    Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com

    Steven E. Sckolnik

    Recruiting

  • Smilow Cancer Hospital Care Center at Glastonbury

    Glastonbury, Connecticut, 06033

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Kevin L. Du

    Recruiting

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

    Site Public Contact, 312-695-1102

    John P. Hayes

    Recruiting

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

    Site Public Contact, 574-364-2973, cccois@goshenhealth.com

    James A. Wheeler

    Recruiting

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

    Suspended

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

    Site Public Contact, 312-695-1102

    John P. Hayes

    Recruiting

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

    Site Public Contact, 937-569-7515

    Tarek M. Sabagh

    Recruiting

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

    Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org

    Joshua C. Farris

    Recruiting

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

    Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org

    Joshua C. Farris

    Recruiting

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Kevin L. Du

    Recruiting

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Shelby Lane

    Recruiting

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Kevin L. Du

    Recruiting

  • Smilow Cancer Hospital-Hamden Care Center

    Hamden, Connecticut, 06518

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Kevin L. Du

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Site Public Contact, 212-639-7592

    Marsha Reyngold

    Recruiting

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Kevin L. Du

    Recruiting

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

    Site Public Contact, 708-799-9995

    Thomas J. Saphner

    Recruiting

  • Northwest Cancer Center - Hobart

    Hobart, Indiana, 46342

    Site Public Contact, 219-947-1795

    Daniel H. Barnett

    Recruiting

  • Saint Mary Medical Center

    Hobart, Indiana, 46342

    Site Public Contact, 219-836-6875, CancerResearch@COMHS.org

    Daniel H. Barnett

    Recruiting

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-524-6115, i.webster@hawaiicancercare.com

    Jared Hara

    Recruiting

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-532-0315

    Jared Hara

    Recruiting

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-545-8548

    Jared Hara

    Recruiting

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-522-4333

    Jared Hara

    Recruiting

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-586-2979

    Jared Hara

    Recruiting

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

    Site Public Contact, 808-547-9816

    Jared Hara

    Recruiting

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

    Site Public Contact, 808-531-8521

    Jared Hara

    Recruiting

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

    Suspended

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

    Site Public Contact, 808-983-6090

    Jared Hara

    Recruiting

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 713-798-1354, burton@bcm.edu

    Alexander N. Hanania

    Recruiting

  • Ben Taub General Hospital

    Houston, Texas, 77030

    Site Public Contact, 713-873-2000

    Alexander N. Hanania

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Site Public Contact, 713-790-2700

    Kevin T. Tran

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Ethan B. Ludmir

    Recruiting

  • Methodist Willowbrook Hospital

    Houston, Texas, 77070

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Kevin T. Tran

    Recruiting

  • UT MD Anderson - West Houston

    Houston, Texas, 77079

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Ethan B. Ludmir

    Recruiting

  • Houston Methodist West Hospital

    Houston, Texas, 77094

    Site Public Contact, 832-522-2873

    Kevin T. Tran

    Recruiting

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

    Site Public Contact, 304-399-6566, Christina.Cole@chhi.org

    Toni O. Pacioles

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    David S. Hong

    Recruiting

  • Allegiance Health

    Jackson, Michigan, 49201

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Parag J. Parikh

    Recruiting

  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

    Site Public Contact, 412-359-3043, ddefazio@wpahs.org

    Paul B. Renz

    Recruiting

  • Regional Cancer Center at Johnson City Medical Center

    Johnson City, Tennessee, 37604

    Site Public Contact, 423-431-5654, charles.mays@balladhealth.org

    Kyle T. Colvett

    Recruiting

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401

    Site Public Contact, 870-936-7066, Emily.Carvell@bmhcc.org

    Shelby Lane

    Recruiting

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

    Site Public Contact, 574-647-7370

    Kathleen Y. Butler

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    David Akhavan

    Recruiting

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    David Akhavan

    Recruiting

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Site Public Contact, 858-822-5354, cancercto@ucsd.edu

    Michael V. Sherer

    Recruiting

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

    Site Public Contact, cancertrials@northwestern.edu

    John P. Hayes

    Recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org

    Samir Narayan

    Recruiting

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

    Site Public Contact, 785-505-2800, Stephanie.Norris@LMH.ORG

    David Akhavan

    Recruiting

  • UT MD Anderson - League City

    League City, Texas, 77573

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Ethan B. Ludmir

    Recruiting

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

    Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu

    Bassem I. Zaki

    Recruiting

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    David Akhavan

    Recruiting

  • Inova Loudoun Hospital

    Leesburg, Virginia, 20176

    Site Public Contact, 703-858-6000, Keary.janet@inova.org

    Tobias R. Chapman

    Recruiting

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

    Site Public Contact, 570-523-9200, cancerresearch@geisinger.edu

    Austin J. Iovoli

    Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    Rafael Ferreira de Carvalho

    Recruiting

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

    Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com

    Thomas J. Saphner

    Recruiting

  • Condell Memorial Hospital

    Libertyville, Illinois, 60048

    Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com

    Thomas J. Saphner

    Recruiting

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

    Site Public Contact, 808-535-7960

    Jared Hara

    Recruiting

  • AdventHealth Littleton

    Littleton, Colorado, 80122

    Site Public Contact, research.institute@adventhealth.com

    Matthew B. Spraker

    Recruiting

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • West Jefferson Medical Center

    Marrero, Louisiana, 70072

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Kareem Fakhoury

    Recruiting

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Bevan Ly

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Daniel H. Barnett

    Recruiting

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginia, 23116

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Christopher Chipko

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Shelby Lane

    Recruiting

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

    Site Public Contact, 262-257-5100

    William A. Hall

    Recruiting

  • Miami Cancer Institute

    Miami, Florida, 33176

    Site Public Contact, 786-596-2000

    Michael D. Chuong

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Site Public Contact, 212-639-7592

    Marsha Reyngold

    Recruiting

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginia, 23114

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Christopher Chipko

    Recruiting

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    William A. Hall

    Recruiting

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

    Site Public Contact, 212-263-4432, cancertrials@nyulangone.org

    Anand Mahadevan

    Recruiting

  • Memorial Medical Center

    Modesto, California, 95355

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Forbes Hospital

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-858-7746

    Paul B. Renz

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Site Public Contact, 212-639-7592

    Marsha Reyngold

    Recruiting

  • Palo Alto Medical Foundation-Camino Division

    Mountain View, California, 94040

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • The Community Hospital

    Munster, Indiana, 46321

    Site Public Contact, 219-836-3349

    Daniel H. Barnett

    Recruiting

  • Women's Diagnostic Center - Munster

    Munster, Indiana, 46321

    Site Public Contact, 219-934-8869, mnicholson@comhs.org

    Daniel H. Barnett

    Recruiting

  • Houston Methodist Saint John Hospital

    Nassau Bay, Texas, 77058

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Kevin T. Tran

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Union County

    New Albany, Mississippi, 38652

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Shelby Lane

    Recruiting

  • Smilow Cancer Center/Yale-New Haven Hospital

    New Haven, Connecticut, 06510

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Kevin L. Du

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Kevin L. Du

    Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Kareem Fakhoury

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

    Site Public Contact, CancerTrials@nyulangone.org

    Anand Mahadevan

    Recruiting

  • Mount Sinai West

    New York, New York, 10019

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Karyn A. Goodman

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Karyn A. Goodman

    Recruiting

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

    Site Public Contact, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu

    David P. Horowitz

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Site Public Contact, 212-639-7592

    Marsha Reyngold

    Recruiting

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Kevin L. Du

    Recruiting

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

    Site Public Contact, 203-852-2996, jennifer.long@norwalkhealth.org

    Philip Gilbo

    Recruiting

  • Henry Ford Medical Center-Columbus

    Novi, Michigan, 48377

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Parag J. Parikh

    Recruiting

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Northwestern Medicine Oak Brook

    Oak Brook, Illinois, 60523

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    John P. Hayes

    Recruiting

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

    Site Public Contact, 414-805-0505

    William A. Hall

    Recruiting

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

    Site Public Contact, 800-323-8622

    Thomas J. Saphner

    Recruiting

  • The University of Kansas Cancer Center - Olathe

    Olathe, Kansas, 66061

    Site Public Contact, 913-588-1569, OlatheCCResearch@kumc.edu

    David Akhavan

    Recruiting

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

    Site Public Contact, 402-559-5600

    Chi Lin

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Chi Lin

    Recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    David S. Hong

    Recruiting

  • AdventHealth Orlando

    Orlando, Florida, 32803

    Site Public Contact, 407-303-2090, FH.Cancer.Research@flhosp.org

    Amit K. Chowdhry

    Recruiting

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    David Akhavan

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Oxford

    Oxford, Mississippi, 38655

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Shelby Lane

    Recruiting

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

    Site Public Contact, 650-498-7061, ccto-office@stanford.edu

    Erqi Pollom

    Recruiting

  • Advocate High Tech Medical Park

    Palos Heights, Illinois, 60463

    Site Public Contact, ncorp@aah.org

    Thomas J. Saphner

    Recruiting

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

    Suspended

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Site Public Contact, 847-384-3621

    Thomas J. Saphner

    Recruiting

  • AdventHealth Parker

    Parker, Colorado, 80138

    Site Public Contact, research.institute@adventhealth.com

    Matthew B. Spraker

    Recruiting

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Arizona Center for Cancer Care-Peoria

    Peoria, Arizona, 85381

    Site Public Contact, 623-773-2873

    Steven E. Sckolnik

    Recruiting

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Joseph M. Caster

    Recruiting

  • Jefferson Torresdale Hospital

    Philadelphia, Pennsylvania, 19114

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Joseph M. Caster

    Recruiting

  • Banner-University Medical Center Phoenix

    Phoenix, Arizona, 85006

    Site Public Contact, BannerResearch@bannerhealth.com

    Gary V. Walker

    Recruiting

  • Arizona Center for Cancer Care - Phoenix

    Phoenix, Arizona, 85027

    Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com

    Steven E. Sckolnik

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Site Public Contact, 877-284-2000

    Paul B. Renz

    Recruiting

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Site Public Contact, 412-578-5000

    Paul B. Renz

    Recruiting

  • Michigan Healthcare Professionals Pontiac

    Pontiac, Michigan, 48341

    Site Public Contact, 248-858-6215, Emily.Crofts@trinity-health.org

    Samir Narayan

    Recruiting

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • MaineHealth Maine Medical Center - Portland

    Portland, Maine, 04102

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Matthew D. Cheney

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Site Public Contact, 503-494-1080, trials@ohsu.edu

    Aaron J. Grossberg

    Recruiting

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601

    Site Public Contact, 845-483-6483

    Sean A. Koerner

    Recruiting

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Site Public Contact, 401-444-1488

    Sherise Rogers

    Recruiting

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Renown Regional Medical Center

    Reno, Nevada, 89502

    Site Public Contact, 775-982-5050, Renown-CRD@renown.org

    Garrett B. Green

    Recruiting

  • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Bevan Ly

    Recruiting

  • Bon Secours Saint Mary's Hospital

    Richmond, Virginia, 23226

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Christopher Chipko

    Recruiting

  • Bon Secours Cancer Institute at Reynolds Crossing

    Richmond, Virginia, 23230

    Site Public Contact, 804-893-8978, Anne_caramella@bshsi.org

    Christopher Chipko

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Sutter Roseville Medical Center

    Roseville, California, 95661

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Dartmouth Cancer Center - North

    Saint Johnsbury, Vermont, 05819

    Site Public Contact, 800-639-6918, cancer.research.nurse@hitchcock.org

    Bassem I. Zaki

    Recruiting

  • Salina Regional Health Center

    Salina, Kansas, 67401

    Site Public Contact, 785-452-7038, mleepers@srhc.com

    David Akhavan

    Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Site Public Contact, 210-450-3800, phoresearchoffice@uthscsa.edu

    Amy E. Le

    Recruiting

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Mills Health Center

    San Mateo, California, 94401

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • MaineHealth Cancer Care Center of York County

    Sanford, Maine, 04073

    Site Public Contact, 207-459-1600

    Matthew D. Cheney

    Recruiting

  • Ridley-Tree Cancer Center

    Santa Barbara, California, 93105

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Mission Hope Medical Oncology - Santa Maria

    Santa Maria, California, 93444

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

    Site Public Contact, 415-209-2683, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

    Site Public Contact, 912-350-7887, Lorraine.OHara@hcahealthcare.com

    Michael D. Hasselle

    Recruiting

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Matthew D. Cheney

    Recruiting

  • Arizona Center for Cancer Care - Scottsdale

    Scottsdale, Arizona, 85258

    Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com

    Steven E. Sckolnik

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Site Public Contact, 800-804-8824

    Edward Y. Kim

    Recruiting

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

    Site Public Contact, 800-804-8824

    Edward Y. Kim

    Recruiting

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

    Site Public Contact, 605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

    Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org

    Daniel Almquist

    Recruiting

  • MaineHealth Cancer Care and IV Therapy - South Portland

    South Portland, Maine, 04106

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Matthew D. Cheney

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Desoto

    Southhaven, Mississippi, 38671

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Shelby Lane

    Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Site Public Contact, 217-545-7929

    Bryan A. Faller

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62702

    Site Public Contact, 800-444-7541

    Bryan A. Faller

    Recruiting

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

    Site Public Contact, 217-528-7541, pallante.beth@mhsil.com

    Bryan A. Faller

    Recruiting

  • Aspirus Cancer Care - Stevens Point

    Stevens Point, Wisconsin, 54481

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Bevan Ly

    Recruiting

  • UT MD Anderson - Sugar Land

    Sugar Land, Texas, 77478

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Ethan B. Ludmir

    Recruiting

  • Houston Methodist Sugar Land Hospital

    Sugar Land, Texas, 77479

    Site Public Contact, 281-242-2873

    Kevin T. Tran

    Recruiting

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Palo Alto Medical Foundation-Sunnyvale

    Sunnyvale, California, 94086

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Arizona Center for Cancer Care-Surprise

    Surprise, Arizona, 85374

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Steven E. Sckolnik

    Recruiting

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

    Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org

    Eric P. Kielhorn

    Recruiting

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    Tampa, Florida, 33607

    Site Public Contact, 813-357-0849, jennifer.manns@baycare.org

    Bansi Savla

    Recruiting

  • MyMichigan Medical Center Tawas

    Tawas City, Michigan, 48764

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Arizona Center for Cancer Care

    Tempe, Arizona, 85284

    Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com

    Steven E. Sckolnik

    Recruiting

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

    Site Public Contact, 718-379-6866, eskwak@montefiore.org

    Byung-Han Rhieu

    Recruiting

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

    Site Public Contact, 718-379-6866, eskwak@montefiore.org

    Byung-Han Rhieu

    Recruiting

  • Houston Methodist The Woodlands Hospital

    The Woodlands, Texas, 77385

    Site Public Contact, 713-790-2700, hmthewoodlands@houstonmethodist.org

    Kevin T. Tran

    Recruiting

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo, Ohio, 43606

    Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org

    Eric P. Kielhorn

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Site Public Contact, 780-432-8500

    Kurian Joseph

    Recruiting

Other trials in Canada

About this study

Official title: A Phase III Randomized Trial of Dose Escalated Radiation in Locally Advanced Pancreas Cancer (LAPC) Patients (LAP100)

This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-8 months of chemotherapy. Usual care options include additional chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may delay tumor growth but have not been shown to improve survival. Radiation therapy uses high energy X-rays to kill cancer cells and shrink tumors. Dose-escalated radiation therapy involves the precise delivery of higher doses to the tumor, often over a shorter period of time. This trial assesses whether using dose-escalated radiation therapy can prolong survival.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate whether dose-escalated radiation therapy (RT) improves 3-year overall survival (OS) compared to standard treatments without dose-escalated RT, in locally advanced pancreatic cancer patients without radiographic progression and with biochemical response after an initial interval of chemotherapy.

SECONDARY OBJECTIVES:

  1. To evaluate and compare local progression between the two treatment arms. II. To evaluate and compare progression-free survival (PFS) between the two treatment arms.

III. To evaluate and compare chemotherapy-free interval between the two treatment arms.

IV. To evaluate and compare toxicity within and between the two treatment arms.

HEALTH-RELATED QUALITY-OF-LIFE (HRQOL) OBJECTIVES:

  1. Primary: To compare Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Total Score at 6 months between the two treatment arms.

II. Secondary: To compare nadir of HRQoL scores over course of study participation between the two treatment arms.

III. Secondary: To evaluate HRQoL scores over time between the two treatment arms.

EXPLORATORY OBJECTIVE:

  1. Biospecimen collection for future correlative analyses.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (STANDARD OF CARE): Patients are assigned to 1 of 3 treatment options per physician's decision.

OPTION 1: Patients continue to receive fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (FOLFIRINOX or modified FOLFIRINOX [mFOLFIRINOX]) or fluorouracil, liposomal irinotecan, leucovorin calcium, and oxaliplatin (NALIRIFOX) or gemcitabine/nab-paclitaxel with or without tumor treating fields therapy per standard of care for a total of 6 months of treatment. Patients may continue treatment beyond 6 months at physician's discretion.

OPTION 2: Patients undergo standard dose radiation therapy once daily for 28 or 30 fractions and receive concurrent fluorouracil or capecitabine per standard of care during radiation therapy. After completing concurrent chemoradiation, patients who received less than 6 months of chemotherapy at study entry are encouraged to receive the remaining chemotherapy to total 6 months of chemotherapy. Patients may continue chemotherapy treatment beyond 6 months at physician's discretion.

OPTION 3: Patients undergo observation per standard of care. (It is recommended [but not required] that this option only be for patients that have already completed total 6 months chemotherapy pre-randomization.)

Additionally, patients undergo blood sample collection, computed tomography (CT), magnetic resonance imaging (MRI) and tumor tissue biopsy throughout the study. Patients may optionally undergo positron emission tomography (PET)/CT prior to treatment.

ARM II (DOSE-ESCALATED RADIATION THERAPY): Patients undergo dose-escalated RT daily, every other day, or twice weekly for 5 fractions or daily for 25 fractions (with or without concurrent fluorouracil or capecitabine for 25 fractions only). The 5-fraction regimen is preferred when feasible. After completing dose-escalated RT, patients who received less than 6 months of chemotherapy at study entry are encouraged to receive the remaining chemotherapy to total 6 months of chemotherapy. Patients may continue chemotherapy treatment beyond 6 months at physician's discretion. Additionally, patients undergo blood sample collection, CT, MRI and tumor tissue biopsy throughout the study. Patients may optionally undergo PET/CT prior to treatment.

Patients are followed every 3 months from study entry for 2 years then annually for 3 years.

Being tested
Biopsy Procedure, Biospecimen Collection, Capecitabine, Computed Tomography, Dose-escalated Radiation Therapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo tumor tissue biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • CapecitabineDrug

    Also called Ro 09-1978/000, Xeloda

    Given capecitabine

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT or PET/CT

  • Dose-escalated Radiation TherapyRadiation

    Also called Dose-escalated RT

    Undergo dose-escalated radiation using intensity-modulated radiation therapy treatment planning

  • FluorouracilDrug

    Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione

    Given fluorouracil

  • GemcitabineDrug

    Also called dFdC, dFdCyd, Difluorodeoxycytidine

    Given gemcitabine

  • Irinotecan HydrochlorideDrug

    Also called Campto, Camptosar, Camptothecin 11, Camptothecin-11

    Given irinotecan hydrochloride

  • Irinotecan SucrosofateDrug

    Also called inotecan Hydrochloride as Sucrosulfate Salt Form Liposomal Formulation, Irinotecan Liposome, Irinotecan Sucrosofate Liposome, Irinotecan Sucrosofate-containing Pegylated Liposomal Formulation

    Given liposomal irinotecan

  • Leucovorin CalciumDrug

    Also called Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate

    Given leucovorin calcium

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Nab-paclitaxelDrug

    Also called ABI 007, ABI-007, ABI007, Abraxane

    Given nab-paclitaxel

  • Observation ActivityOther

    Also called Observation

    Undergo observation

  • OxaliplatinDrug

    Also called 1-OHP, Ai Heng, Aiheng, Dacotin

    Given oxaliplatin

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo standard radiation therapy

  • Tumor Treating Fields TherapyProcedure or surgery

    Also called Alternating Electric Field Therapy, TTF, TTFields

    Undergo TTF

Study groups in NCT06958328
Study groupRoleWhat they receive
Arm I (Options 1, 2, or 3)Active comparatorSee Detailed Description.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Capecitabine; Procedure: Computed Tomography; Drug: Fluorouracil; Drug: Gemcitabine; Drug: Irinotecan Hydrochloride; Drug: Irinotecan Sucrosofate; Drug: Leucovorin Calcium; Procedure: Magnetic Resonance Imaging; Drug: Nab-paclitaxel; Other: Observation Activity; Drug: Oxaliplatin; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Radiation: Radiation Therapy; Procedure: Tumor Treating Fields Therapy
Arm II (dose-escalated RT)ExperimentalPatients undergo dose-escalated RT daily, every other day, or twice weekly for 5 fractions or daily for 25 fractions (with or without concurrent fluorouracil or capecitabine for 25 fractions only). The 5-fraction regimen is preferred when feasible. After completing dose-escalated RT, patients who received less than 6 months of chemotherapy at study entry are encouraged to receive the remaining chemotherapy to total 6 months of chemotherapy. Patients may continue chemotherapy treatment beyond 6 months at physician's discretion. Additionally, patients undergo blood sample collection, CT, MRI and tumor tissue biopsy throughout the study. Patients may optionally undergo PET/CT prior to treatment.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Capecitabine; Procedure: Computed Tomography; Radiation: Dose-escalated Radiation Therapy; Drug: Fluorouracil; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    OS will be estimated by the Kaplan-Meier method (Kaplan 1958). The 3-year OS estimates between the two arms will be compared using a Z-test. A logistic regression model will be used to analyze the effects of factors, in addition to treatment, including, but not limited to the stratification factor, which may be associated with 3-year OS. The primary hypothesis of improved 3-year OS will be tested with a 1-sided significance level of 0.023 (level based on not having stopped at either of the 2 planned interim analyses).

    Measured: From randomization to the date of death or last follow-up, assessed up to 3 years

Secondary outcomes (5)

  1. Local progression (LP)

    Defined as progression of the primary tumor/nodes as determined by Response Evaluation Criteria in Solid Tumors criteria. LP will be estimated by the cumulative incidence method (Kalbfleish 1980), with death as a competing risk, and compared between treatment arms using Gray's test (Gray 1988). The Fine-Gray regression model will be used to analyze the effects of factors, in addition to treatment, which may be associated with LP (Fine 1999).

    Measured: From randomization to date of failure, date of death (competing event), or last known follow-up date, assessed up to 5 years

  2. Progression-free survival (PFS)

    Defined as local progression, distant failure, or death due to any cause. PFS will be estimated by the Kaplan-Meier method (Kaplan 1958) and estimates between treatment arms will be compared using the log-rank test (Mantel 1966). The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, which may be associated with PFS (Cox 1972).

    Measured: From the date of randomization to the date of first PFS failure or last follow-up for patients without a reported PFS event, assessed up to 5 years

  3. Chemotherapy-free interval (CFI)

    Defined as the time in months without chemotherapy for locally advanced pancreatic cancer post the initial chemotherapy treatment. Mean CFI will be compared between treatment arms using a Z-test. Regression modeling will be used to analyze the effects of factors, in addition to treatment, which may be associated with CFI.

    Measured: From the date of last dose of initial chemotherapy to the date of first dose of second line chemotherapy for progression, assessed up to 5 years

  4. Long-term radiation-related ≥ grade 3 adverse events

    The percentage of patients on the dose-escalated radiation therapy arm will be reported.

    Measured: Up to 1 year after randomization

  5. Incidence of ≥ grade 3 adverse events

    The percentage of patients will be compared between the treatment arms using a Z-test.

    Measured: Up to 90 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2025
  2. Study start21 Aug 2025
  3. Primary completion21 Oct 2030 (estimated)
  4. Study completion21 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
356 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06958328
Sponsor's protocol ID
NRG-GI011
Other IDs
NCI-2025-01624, NRG-GI011, NRG-GI011, U10CA180868
Acronym
LAP100
Status last verified
Aug 2026
First submitted
25 Apr 2025
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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