AzTrials
AzTrials

Head and Neck CancerPhase 2NCT01220583

Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery

A Phase 2 study testing cisplatin, 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy in people with Head and Neck Cancer, run by Radiation Therapy Oncology Group at 268 sites in 3 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
cisplatin, 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
268 sitesin 3 countries
Study dates
Jan 2011to 31 Dec 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

DISEASE CHARACTERISTICS:

  • Pathologically proven diagnosis of a malignant major salivary gland tumor or malignant minor salivary gland tumor of the head and neck of the following histologic subtypes:
  • Intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid carcinoma
  • High-grade acinic cell carcinoma or high-grade (>30% solid component) adenoid cystic carcinoma
  • Surgical resection with curative intent within 8 weeks prior to registration
  • All patients must have a Medical Oncology evaluation within 4 weeks prior to registration
  • Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 1mm) or microscopically positive surgical margin; patients must be free of distant metastases based upon the following minimum diagnostic workup:
  • History/physical examination within 8 weeks prior to registration
  • Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration; at a minimum, contrast CT imaging of the chest is required (PET/CT is acceptable)
  • No patients with residual macroscopic disease after surgery
  • No prior systemic chemotherapy or radiation therapy for salivary gland malignancy

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3
  • Platelets ≥ 100,000 cells/mm^3
  • Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable)
  • Serum creatinine < 2.0 mg/dL
  • Total bilirubin < 2 x the institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN
  • Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
  • Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment
  • Not pregnant or nursing
  • Patients must be deemed able to comply with the treatment plan and follow-up schedule
  • Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review
  • No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • No severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (coagulation parameters are not required for entry into this protocol)
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition (HIV testing is not required for entry into this protocol)
  • Protocol-specific requirements may also exclude immunocompromised patients
  • Pre-existing ≥ grade 2 neuropathy
  • No significant pre-existing hearing loss, as defined by the patient or treating physician

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic chemotherapy or radiation therapy for salivary gland malignancy (prior chemotherapy for a different cancer is allowable)
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • No prior organ transplant
  • No concurrent hematopoietic growth factors (e.g., G-CSF or pegfilgrastim) during radiotherapy
  • No concurrent erythropoiesis-stimulating agents

Trial locations and contacts

268 sites in 3 countries.

268 sites in 3 countries

United States259 sites

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Emory Proton Therapy Center

    Atlanta, Georgia, 30308

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • AIS Cancer Center at San Joaquin Community Hospital

    Bakersfield, California, 93301

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Summa Health System - Barberton Campus

    Barberton, Ohio, 44203

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • The Kirklin Clinic at Acton Road

    Birmingham, Alabama, 35243

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • IU Health North Hospital

    Carmel, Indiana, 46032

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Arizona Breast Cancer Specialists-Gilbert

    Gilbert, Arizona, 85297

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Sentara Cancer Institute at Sentara CarePlex Hospital

    Hampton, Virginia, 23666

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • MD Anderson West Houston

    Houston, Texas, 77079

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • University of Florida Health Science Center - Jacksonville

    Jacksonville, Florida, 32209

  • Freeman Health System

    Joplin, Missouri, 64804

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • MD Anderson League City

    League City, Texas, 77573

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • McKee Medical Center

    Loveland, Colorado, 80539

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Summa Health Medina Medical Center

    Medina, Ohio, 44256

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Miami Cancer Institute

    Miami, Florida, 33176

  • UH Seidman Cancer Center at Southwest General Hospital

    Middleburg Heights, Ohio, 44130

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Memorial Medical Center

    Modesto, California, 95355

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • UPMC-Coraopolis/Heritage Valley Radiation Oncology

    Moon Township, Pennsylvania, 15108

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Virtua Memorial

    Mount Holly, New Jersey, 08060

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • UPMC Jameson

    New Castle, Pennsylvania, 16105

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • Touro Infirmary

    New Orleans, Louisiana, 70115

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Mount Sinai Union Square

    New York, New York, 10003

  • Mount Sinai Chelsea

    New York, New York, 10011

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Lenox Hill Hospital

    New York, New York, 10021

  • Mount Sinai Hospital

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

  • Hoag Memorial Hospital

    Newport Beach, California, 92663

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • William Backus Hospital

    Norwich, Connecticut, 06360

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Saint Joseph Hospital - Orange

    Orange, California, 92868

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • University Hospitals Parma Medical Center

    Parma, Ohio, 44129

  • Arizona Center for Cancer Care-Peoria

    Peoria, Arizona, 85381

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004

  • Arizona Breast Cancer Specialists-Phoenix

    Phoenix, Arizona, 85027

  • Arizona Oncology-Deer Valley Center

    Phoenix, Arizona, 85027

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • UPMC Jefferson Regional Radiation Oncology

    Pittsburgh, Pennsylvania, 15236

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

  • UPMC-Saint Clair Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Lake Huron Medical Center

    Port Huron, Michigan, 48060

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Highland Hospital

    Rochester, New York, 14620

  • University of Rochester

    Rochester, New York, 14642

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Ascension Saint Mary's Hospital

    Saginaw, Michigan, 48601

  • Norris Cotton Cancer Center-North

    Saint Johnsbury, Vermont, 05819

  • UH Seidman Cancer Center at Salem Regional Medical Center

    Salem, Ohio, 44460

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

  • UH Seidman Cancer Center at Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Arizona Breast Cancer Specialists

    Scottsdale, Arizona, 85251

  • Arizona Breast Cancer Specialists-Scottsdale

    Scottsdale, Arizona, 85258

  • Arizona Oncology Services Foundation

    Scottsdale, Arizona, 85260

  • Seattle Cancer Care Alliance at Northwest Hospital

    Seattle, Washington, 98133

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Memorial Sloan Kettering Sleepy Hollow

    Sleepy Hollow, New York, 10591

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Sparta Cancer Treatment Center

    Sparta, New Jersey, 07871

  • Saint John's Hospital

    Springfield, Illinois, 62702

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • SSM Health Saint Louis University Hospital

    St Louis, Missouri, 63104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Dixie Medical Center Regional Cancer Center

    St. George, Utah, 84770

  • Saint Vincent Hospital Cancer Center at Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235-1495

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • Arizona Center for Cancer Care-Surprise

    Surprise, Arizona, 85374

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Rocky Mountain Cancer Centers-Thornton

    Thornton, Colorado, 80260

  • University of Toledo

    Toledo, Ohio, 43614

  • Mercy Health - Saint Anne Hospital

    Toledo, Ohio, 43623

  • University of Arizona Cancer Center-Orange Grove Campus

    Tucson, Arizona, 85704

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

  • Sutter Cancer Centers Radiation Oncology Services-Vacaville

    Vacaville, California, 95687

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

  • Compass Oncology Vancouver

    Vancouver, Washington, 98684

  • Sentara Virginia Beach General Hospital

    Virginia Beach, Virginia, 23454

  • Virtua Voorhees

    Voorhees Township, New Jersey, 08043

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069

  • Wheeling Hospital/Schiffler Cancer Center

    Wheeling, West Virginia, 26003

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Canada8 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • The Research Institute of the McGill University Health Centre (MUHC)

    Montreal, Quebec, H3H 2R9

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Saudi Arabia1 site

  • King Faisal Specialist Hospital and Research Centre

    Riyadh, 11211

Other trials in Saudi Arabia

About this study

Official title: A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors.

PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

Phase II

  • Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors.
  • Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.

Phase III

  • Compare overall survival rates among patients receiving cisplatin and radiation to those receiving radiation alone.

Secondary

Phase II/III

  • Compare the acute toxicities of these 2 adjuvant treatments.
  • Compare late treatment-related adverse events in patients receiving postoperative radiation to those receiving concurrent chemoradiation.
  • Compare progression-free survival rates among patients receiving cisplatin and radiation to those receiving radiation alone in both the cohort of patients with pathologically high-risk disease (high-grade adenocarcinoma, high-grade mucoepidermoid carcinoma, salivary duct carcinoma), and the patient cohort with pathologically intermediate-risk disease (all other eligible diagnoses).
  • Investigate quality of life and patient-reported outcomes in patients enrolled in the study.
  • Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies.
  • Establish a NRG Oncology baseline database for salivary gland malignancies to serve as a resource for future exploration of innovative and/or targeted approaches for this disease.

OUTLINE: This is a multicenter study. Patients are stratified according to histology (high-grade mucoepidermoid carcinoma vs salivary duct carcinoma vs high-grade adenocarcinoma) and nodal status (N0 vs N1-3). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.
  • Arm II: Patients undergo 3D-CRT or IMRT as in Arm I. Tissue and blood samples may be collected for translational research studies. Patients may complete quality-of-life assessments periodically.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, and 24 months, every 6 months for 2 years, and then annually thereafter.

Being tested
cisplatin, 3-dimensional conformal radiation therapy, intensity-modulated radiation therapy
Keywords
stage I salivary gland cancer, stage II salivary gland cancer, stage III salivary gland cancer, high-grade salivary gland mucoepidermoid carcinoma, salivary gland adenocarcinoma, stage IVA salivary gland cancer, stage IVB salivary gland cancer, stage IVC salivary gland cancer
Medical subject headings
Head and Neck Neoplasms, Salivary Gland Neoplasms

What participants receive

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

  • cisplatinDrug

    Given IV

  • 3-dimensional conformal radiation therapyRadiation

    Undergo radiotherapy

  • intensity-modulated radiation therapyRadiation

    Undergo radiotherapy

Study groups in NCT01220583
Study groupRoleWhat they receive
Arm IExperimentalPatients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.
Receives: Drug: cisplatin; Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy
Arm IIExperimentalPatients undergo 3D-CRT or IMRT as in arm I.
Receives: Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy

What is being measured

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

  1. Progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause, primarily at 2 years

    Measured: From randomization to 2 years.

Secondary outcomes (8)

  1. Overall survival (OS) rate at 2 years

    Measured: From randomization to 2 years.

  2. PFS rate at 5 years

    Measured: From randomization to 5 years.

  3. OS rate at 5 years

    Measured: From randomization to 5 years.

  4. Treatment-related toxicity, defined as any grade 3-4 adverse events (CTCAE v. 4) deemed to be definitely, probably, or possibly related to protocol treatment

    Measured: From start of treatment to last follow-up.

  5. Treatment-related mortality, defined as any death during or within 30 days of discontinuation of protocol treatment

    Measured: From start of treatment to 30 days after the end of treatment.

  6. Chemotherapy delivery as measured by percentage of protocol prescription given

    Measured: From start of treatment to end of treatment.

  7. Radiation delivery as measured by elapsed treatment days

    Measured: From start of treatment to end of treatment.

  8. Determine whether quality of life, fatigue and xerostomia differ as a function of treatment assignment at 3, 12, and 24 months after completing radiotherapy.

    Measured: From randomization to 2 years.

Timeline

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

  1. First posted14 Oct 2010 (estimated)
  2. Study startJan 2011
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2031 (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
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01220583
Sponsor's protocol ID
RTOG-1008
Other IDs
CDR0000686072, NCI-2013-00370
Status last verified
Oct 2026
First submitted
12 Oct 2010
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Publications

  • Joshi NP, Broughman JR. Postoperative Management of Salivary Gland Tumors. Curr Treat Options Oncol. 2021 Feb 9;22(3):23. doi: 10.1007/s11864-021-00820-9.

    PubMed 33560478

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy in people with Head and Neck Cancer, run by Radiation Therapy Oncology Group at 268 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 268 sites in United States, Canada, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause, primarily at 2 years (time frame: From randomization to 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01220583, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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