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AzTrials

Metastatic Pancreatic Neuroendocrine TumorPhase 2NCT05247905

Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors, the ComPareNET Trial

A Phase 2 study testing Lutetium Lu 177 Dotatate, Capecitabine and Temozolomide in people with Metastatic Pancreatic Neuroendocrine Tumor and Unresectable Pancreatic Neuroendocrine Carcinoma, run by Alliance for Clinical Trials in Oncology at 171 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This phase II trial compares the effect of combination therapy with capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or that cannot be removed by surgery (unresectable). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lutetium Lu 177 Dotatate, Capecitabine and Temozolomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
171 sitesUnited States
Study dates
16 Feb 2023to 1 Apr 2033
Phase
Phase 2

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

  • Histologic or pathologic documentation: well-differentiated pancreatic neuroendocrine tumor (G1, G2, or well-differentiated G3) confirmed by local histology and/or pathology
  • Functional or nonfunctional tumors are allowed
  • Patients with poorly differentiated neuroendocrine carcinoma (including large cell histology or small cell histology) are not eligible
  • Stage: locally unresectable or metastatic disease
  • Tumor Site: neuroendocrine tumor of pancreatic primary site
  • Radiologic evaluation: tumor must have shown somatostatin receptor (SSTR) positivity on 68Ga-DOTATATE PET or other SSTR-PET scan in the 12 months prior to registration; however, documentation of SSTR positivity in the 6 months prior to registration is preferred. SSTR positivity is defined as uptake greater than background liver in all measurable lesions
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  • Patients are eligible if they meet one of the following criteria:
  • Previously untreated patients with grade 2 or 3 disease AND with symptoms of either disease bulk causing pain, anorexia, early satiety, large effusions/ascites, abdominal pain, abdominal fullness due to hepatomegaly, dyspnea) OR incompletely controlled symptoms of hormone excess despite somatostatin analogue (SSA) and supportive care (including but not limited to: diarrhea, hypercalcemia, hypoglycemia, hyperglycemia, flushing, Cushing's syndrome). Patient may have been started on SSA for up to 2 months for attempted symptom control without disease progression prior to registration
  • Patients previously treated with SSA only
  • Any patient with disease progression by RECIST criteria in < 4 months
  • Patients must have measurable disease per RECIST v1.1 by computer tomography (CT) scan or magnetic imaging (MRI). Any lesions which have undergone percutaneous therapies or radiotherapy after starting protocol therapy should not be considered measurable unless the lesion has clearly progressed since the procedure.
  • Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as >= 1 cm with CT or MRI (or shortest diameter >= 1.5 cm for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly non- measurable including: leptomeningeal disease, bone metastases, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung.
  • No prior temozolomide, dacarbazine, capecitabine, 5-FU, or any PRRT for treatment of the pNET
  • Prior treatment with tyrosine kinase inhibitors (TKIs) such as mammalian target of rapamycin (mTOR) inhibitors (e.g. everolimus, temsirolimus, etc.) or VEGF pathway inhibitors (e.g. sunitinib, pazopanib, cabozantinib, bevacizumab, etc.) are allowed
  • Prior treatment with hepatic intra-arterial embolic therapies is allowed if there is recovery from all toxicities, measurable lesions do not include embolized liver unless there has been clear subsequent progression, all measurable lesions are somatostatin receptor avid, and treatment completed at least 2 months prior to registration
  • Prior treatment with cryoablation or thermal/radiofrequency ablation of metastases is allowed if there is recovery from all toxicities, measurable lesions do not include treated metastases, and treatment completed at least 2 months prior to registration
  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects
  • Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 9.0 g/dL
  • Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min (calculated by the Cockcroft-Gault equation)
  • Total bilirubin =< 1.5 x ULN (in patients with liver metastases or known Gilbert's syndrome, total bilirubin must be =< 3.0 x ULN)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x ULN
  • Albumin >= 3.0 g/dL
  • No known brain metastases unless adequately treated, demonstrated to be stable, and off all treatment (including steroids) for at least 2 months prior to registration
  • No uncontrolled congestive heart failure (New York Heart Association [NYHA] II, III, IV).
  • No significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may pose a risk to patient safety
  • No "currently active" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy or are on adjuvant hormonal therapy and are free of disease for >= 3 years
  • No known medical condition causing an inability to swallow and no known impairment of gastrointestinal function that may significantly alter the absorption of an oral agent
  • Concurrent somatostatin analog use while on protocol therapy is allowed provided that the patient:
  • Has a functional tumor (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome)
  • Has been on a stable dose of somatostatin analog therapy for at least three months
  • Has previously demonstrated radiographic disease progression while on somatostatin analog therapy. For subjects receiving lutetium Lu 177 dotatate, there should be a minimum of 28 days between long-acting somatostatin analogue and lutetium Lu 177 dotatate dosing. Short-acting somatostatin analogs should not be administered within 24 hours of lutetium Lu 177 dotatate dosing. Following lutetium Lu 177 dotatate dosing, long-acting somatostatin analogs may be administered between 4 and 24 hours after each dose

Who cannot join

None listed.

Trial locations and contacts

171 sites in 1 country.

171 sites in 1 country

United States171 sites

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • Advocate Outpatient Center - Aurora

    Aurora, Illinois, 60506

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

  • Epic Care-Dublin

    Dublin, California, 94568

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Rocky Mountain Cancer Centers - Swedish

    Englewood, Colorado, 80113

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Smilow Cancer Hospital Care Center at Glastonbury

    Glastonbury, Connecticut, 06033

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Aurora Health Center - Greenfield

    Greenfield, Wisconsin, 53228

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Marshfield Medical Center - Ladysmith

    Ladysmith, Wisconsin, 54848

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

  • Condell Memorial Hospital

    Libertyville, Illinois, 60048

  • Cancer Partners of Nebraska

    Lincoln, Nebraska, 68516

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers-Longmont

    Longmont, Colorado, 80501

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Toledo Clinic Cancer Centers-Monroe

    Monroe, Michigan, 48162

  • Forbes Hospital

    Monroeville, Pennsylvania, 15146

  • Yale University

    New Haven, Connecticut, 06520

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • Mount Sinai Hospital

    New York, New York, 10029

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

  • Advocate Outpatient Center - Oak Lawn

    Oak Lawn, Illinois, 60453

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Smilow Cancer Hospital-Orange Care Center

    Orange, Connecticut, 06477

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Mercy Health - Paducah Cancer Center

    Paducah, Kentucky, 42003

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Jefferson Healthcare

    Port Townsend, Washington, 98368

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Baptist Memorial Hospital and Cancer Center-Desoto

    Southhaven, Mississippi, 38671

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Smilow Cancer Hospital Care Center at Long Ridge

    Stamford, Connecticut, 06902

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • BJC Outpatient Center at Sunset Hills

    Sunset Hills, Missouri, 63127

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • Rocky Mountain Cancer Centers-Thornton

    Thornton, Colorado, 80260

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623

  • Torrance Memorial Physician Network - Cancer Care

    Torrance, California, 90505

  • Smilow Cancer Hospital-Torrington Care Center

    Torrington, Connecticut, 06790

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • Epic Care Cyberknife Center

    Walnut Creek, California, 94597

  • BASS Medical Group - Lennon

    Walnut Creek, California, 94598

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Smilow Cancer Hospital-Waterbury Care Center

    Waterbury, Connecticut, 06708

  • Smilow Cancer Hospital Care Center - Waterford

    Waterford, Connecticut, 06385

  • Marshfield Clinic-Wausau Center

    Wausau, Wisconsin, 54401

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Smilow Cancer Hospital Care Center - Westerly

    Westerly, Rhode Island, 02891

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • Wexford Health and Wellness Pavilion

    Wexford, Pennsylvania, 15090

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • Sanford Cancer Center Worthington

    Worthington, Minnesota, 56187

Other trials in United States

About this study

Official title: Phase II Randomized, Prospective Trial of Lutetium Lu 177 Dotatate PRRT Versus Capecitabine and Temozolomide in Well-Differentiated Pancreatic Neuroendocrine Tumors

This phase II trial compares the effect of combination therapy with capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or that cannot be removed by surgery (unresectable). Temozolomide and capecitabine are considered chemotherapy drugs. Temozolomide is in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid and may kill cancer cells. Capecitabine is in a class of medications called antimetabolites. It is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Lutetium Lu 177-dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate, builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Treatment with lutetium Lu 177 dotatate may be more effective than combination therapy with temozolomide and capecitabine in shrinking or stabilizing cancer in patients with advanced or unresectable neuroendocrine tumors.

Read the detailed description

This phase II trial compares capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic neuroendocrine tumors.

The primary and secondary objectives of the study:

PRIMARY OBJECTIVE:

  1. To determine the differences in median progression-free survival (PFS) for lutetium Lu 177 dotatate peptide receptor radionuclide therapy (PRRT) when compared to capecitabine and temozolomide (CAPTEM) in patients with locally advanced or metastatic progressive, well-differentiated pancreatic neuroendocrine tumors (pNETs).

SECONDARY OBJECTIVES:

  1. To evaluate and compare the overall survival (OS) of patients receiving lutetium Lu 177 dotatate versus (vs.) CAPTEM.

II. To evaluate and compare time to response, time to maximum response, and overall response rates (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 between both arms.

III. To evaluate and compare duration of response and time to progression among both arms.

IV. To evaluate and compare treatment related toxicities between the arms. V. To compare global health status/quality of life as measured with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 from baseline through 18 months between patients with pNET treated with lutetium Lu 177 dotatate PRRT versus capecitabine and temozolomide.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive lutetium Lu 177 dotatate intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples prior to registration, on days 1 and 29 of each cycle, during post-treatment follow-up, and at progressive disease, withdrawal or removal from study. Patients undergo PET prior to registration, and CT and/or magnetic resonance imaging (MRI) prior to registration and then every 3 months until progression.

ARM II: Patients receive capecitabine orally (PO) twice daily (BID) days 1-14 of each cycle and temozolomide PO once daily (QD) on days 10-14 of each cycle. Treatment repeats every 4 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples prior to registration, on day 1 of each cycle, and at progressive disease, withdrawal, or removal from study. Patients undergo PET prior to registration, and CT and/or MRI prior to registration and then every 3 months until progression.

Being tested
Lutetium Lu 177 Dotatate, Capecitabine, Temozolomide, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Adenoma, Islet Cell

What participants receive

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

  • Lutetium Lu 177 DotatateDrug

    Given IV

  • CapecitabineDrug

    Given PO

  • TemozolomideDrug

    Given PO

  • Quality-of-Life AssessmentOther

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT05247905
Study groupRoleWhat they receive
Arm I (lutetium Lu 177 dotatate)ExperimentalPatients receive lutetium Lu 177 dotatate IV over 30 minutes on day 1 of each cycle. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples prior to registration, on days 1 and 29 of each cycle, during post-treatment follow-up, and at progressive disease, withdrawal or removal from study. Patients undergo PET prior to registration, and CT and/or MRI prior to registration and then every 3 months until progression.
Receives: Drug: Lutetium Lu 177 Dotatate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (capecitabine, temozolomide)ExperimentalPatients receive capecitabine PO BID days 1-14 of each cycle and temozolomide PO QD on days 10-14 of each cycle. Treatment repeats every 4 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples prior to registration, on day 1 of each cycle, and at progressive disease, withdrawal, or removal from study. Patients undergo PET prior to registration, and CT and/or MRI prior to registration and then every 3 months until progression.
Receives: Drug: Capecitabine; Drug: Temozolomide; Other: Quality-of-Life Assessment

What is being measured

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

  1. Progression free survival (PFS)

    Progression free survival (PFS) will be compared between the two treatment arms using Kaplan-Meier methods. The hazard ratio (HR) and median PFS will be estimated along with corresponding 95% confidence intervals.

    Measured: Up to 8 years from randomization

Secondary outcomes (10)

  1. Progression Free Survival (PFS) at 2 years

    Kaplan-Meier methodology will be used to estimate the PFS rate at 2 years.

    Measured: At 2 years from randomization

  2. Progression Free Survival (PFS) at 3 years

    Kaplan-Meier methodology will be used to estimate the PFS rate at 3 years.

    Measured: At 3 years from randomization

  3. Time to progression (TTP)

    Kaplan-Meier methodology will be used to estimate the median time to progression (TTP).

    Measured: Up to 8 years from randomization

  4. Overall survival (OS)

    Kaplan-Meier methodology will be used to estimate the median overall survival (OS). OS is defined as randomization to the time of death due to any cause (or censored at the time of last contact for surviving patients and those lost to follow-up).

    Measured: Up to 8 years from study registration

  5. Objective response rate (ORR)

    The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test.

    Measured: Up to 8 years from randomization

  6. Time-to response

    Kaplan-Meier methodology will be used to estimate the median time-to-response. Time-to-response will be defined as the time from randomization to the first tumor response, for those patients having achieved an objective response.

    Measured: Up to 8 years from randomization

  7. Duration of response

    Kaplan-Meier methodology will be used to estimate the median duration of response. Duration of response will be defined as the time from first assessment with documented response (PR or CR) to the time of progression and/or death. Patients who are still responding as of their last evaluation will be censored at the time point. If we observed documented deaths without progression, we will further evaluate this endpoint with death without progression treated as a competing risk.

    Measured: Up to 8 years from randomization

  8. Incidence of adverse events

    Patients will be evaluated for adverse events using the National Cancer Institute Common Toxicity Criteria for Adverse Events version 5.0. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported.

    Measured: Up to 8 years from randomization

  9. Change in Overall Health Question (Q29) from the EORTC QLQ-C30 questionnaire

    To evaluate between-arm differences in patient-reported global health status from baseline through 18 months, the area under the curve will be calculated as a summary statistic for each arm based on estimates from a mixed model for patient-reported global health status/quality of life as assessed by the EORTC QLQ-C30 at baseline, 3, 6, 12, and 18 months.

    Measured: At baseline up to 18 months

  10. Change in Overall Quality of Life Question (Q30) from the EORTC QLQ-C30 questionnaire

    To evaluate between-arm differences in patient-reported quality of life from baseline through 18 months, the area under the curve will be calculated as a summary statistic for each arm based on estimates from a mixed model for patient-reported global health status/quality of life as assessed by the EORTC QLQ-C30 at baseline, 3, 6, 12, and 18 months.

    Measured: At baseline up to 18 months

Timeline

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

  1. First posted21 Feb 2022
  2. Study start16 Feb 2023
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Apr 2033 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05247905
Sponsor's protocol ID
A022001
Other IDs
U10CA180821, NCI-2021-14404
Status last verified
Oct 2026
First submitted
10 Feb 2022
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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