AzTrials
AzTrials

Head and Neck CancerPhase 3NCT00956007

RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer

A Phase 3 study testing cetuximab and intensity-modulated radiation therapy in people with Head and Neck Cancer, run by Radiation Therapy Oncology Group at 264 sites in 4 countries.

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

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. 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?
cetuximab and intensity-modulated radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
702 participants
Where
264 sitesin 4 countries
Study dates
31 Mar 2010to Aug 2029
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Conditions for Patient Eligibility:

  • Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS [not otherwise specified], etc.) of the head/neck (oral cavity, oropharynx or larynx); Note: Hypopharynx primaries are excluded because these patients have both a poor prognosis and high likelihood of post- radiation complications.
  • Clinical stage T1, N1-2 or T2-4a, N0-2, M0 including no distant metastases, based upon the following minimum diagnostic workup:
  • General history and physical examination by a radiation oncologist and/or medical oncologist within 8 weeks prior to registration;
  • Examination by an otolaryngologists or Head \& Neck Surgeon, within 8 weeks prior to registration; a laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) is recommended but not required.
  • Chest x-ray (at a minimum) or chest computed tomography (CT) scan (with or without contrast) or CT/positron emission tomography (PET) of chest (with or without contrast) within 8 weeks prior to registration.
  • Gross total resection of the primary tumor with curative intent must be completed within 7 weeks of registration with surgical pathology demonstrating one or more of the following intermediate risk factors:
  • Perineural invasion;
  • Lymphovascular invasion;
  • Single lymph node > 3 cm or ≥ 2 lymph nodes (all < 6 cm) [no extracapsular extension];
  • Close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin, and/or an initially focally positive margin that is subsequently superseded by intraoperative negative margins. Similarly, patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible.
  • Pathologically confirmed T3 or T4a primary tumor.
  • T2 oral cavity cancer with > 5 mm depth of invasion.
  • Zubrod Performance Status of 0-1 within 2 weeks prior to registration;
  • Age ≥ 18;
  • Complete blood count (CBC)/differential obtained within 4 weeks prior to registration on study, with adequate bone marrow function defined as follows:
  • Absolute granulocyte count (AGC) ≥ 1,500 cells/mm3;
  • Platelets ≥ 100,000 cells/mm3;
  • Hemoglobin (Hgb) ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥8.0 g/dl is acceptable).
  • Adequate hepatic function, defined as follows:
  • Total bilirubin < 2 x institutional upper limit of normal (ULN) within 2 weeks prior to registration;
  • aspartate aminotransferase (AST) or alanine transaminase (ALT) < 3 x institutional ULN within 2 weeks prior to registration.
  • Adequate renal function, defined as follows:
  • Serum creatinine (Scr) < 2 x institutional ULN within 2 weeks prior to registration or; creatinine clearance (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (weight in kg)] /[(SCr mg/dl) x (72)] CCr female = 0.85 x (CCr male)
  • Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential;
  • The following assessments are required within 2 weeks prior to the start of registration:

Na, K, Cl, glucose, Ca, Mg, and albumin. Note: Patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator's discretion.

  • Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control;
  • Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for EGFR and for oropharyngeal patients, HPV analyses.

Conditions for Patient Ineligibility

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago. Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid carcinoma, who are eligible.
  • Per the operative and/or pathology report, positive margin(s) [defined as tumor present at the cut or inked edge of the tumor], nodal extracapsular extension, and/or gross residual disease after surgery; Note: Patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible.
  • Prior systemic chemotherapy or anti-EGF therapy for the study cancer; note: prior chemotherapy or anti-EGF therapy for a different cancer is allowable.
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration;
  • Transmural myocardial infarction within 6 months prior to registration;
  • 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;
  • Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration;
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol.
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note: HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
  • Grade 3-4 electrolyte abnormalities (CTCAE v4):
  • Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or >12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels;
  • Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14mmol/L);
  • Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels;
  • Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels;
  • Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
  • Prior allergic reaction to cetuximab.

Trial locations and contacts

264 sites in 4 countries.

264 sites in 4 countries

United States250 sites

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • Akron General Medical Center

    Akron, Ohio, 44307

  • New York Oncology Hematology PC - Albany

    Albany, New York, 12206

  • University of New Mexico

    Albuquerque, New Mexico, 87106

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Fox Valley Hematology and Oncology

    Appleton, Wisconsin, 54911-3496

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina, 28801

  • Emory University/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 Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Texas Oncology-Austin Midtown

    Austin, Texas, 78705

  • Texas Oncology - Central Austin Cancer Center

    Austin, Texas, 78731

  • Texas Oncology - South Austin Cancer Center

    Austin, Texas, 78745

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Summa Barberton Hospital

    Barberton, Ohio, 44203

  • Memorial Sloan Kettering Cancer Center at Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Texas Oncology PA - Bedford

    Bedford, Texas, 76022

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Saint Vincent's Medical Center

    Bridgeport, Connecticut, 06606

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Sands Cancer Center

    Canandaigua, New York, 14424

  • Mercy Medical Center

    Canton, Ohio, 44708

  • Cape Radiation Oncology

    Cape Girardeau, Missouri, 63703

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Geaugra Hospital

    Chardon, Ohio, 44024

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia

    Charlottesville, Virginia, 22908

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612-3785

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Siteman Cancer Center - Saint Peters

    City of Saint Peters, Missouri, 63376

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Cancer Center Commack

    Commack, New York, 11725

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Oakwood Hospital

    Dearborn, Michigan, 48124

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Texas Oncology-Denton South

    Denton, Texas, 76210

  • 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

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • City of Hope

    Duarte, California, 91010

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Exeter Hospital

    Exeter, New Hampshire, 03833

  • Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Radiation Oncology Associates PC

    Fort Wayne, Indiana, 46804

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • The Klabzuba Cancer Center

    Fort Worth, Texas, 76104

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute/Greenville CCOP

    Greenville, South Carolina, 29615

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Sentara Cancer Institute at Sentara CarePlex Hospital

    Hampton, Virginia, 23666

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Hines Veterans Administration Hospital

    Hines, Illinois, 60141

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Memorial Hermann Memorial City Medical Center

    Houston, Texas, 77024

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Community Regional Cancer Care-East Radiation Oncology

    Indianapolis, Indiana, 46219

  • Community Regional Cancer Care-North

    Indianapolis, Indiana, 46256

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Kansas City Cancer Centers - North

    Kansas City, Missouri, 64154

  • Tri-Cities Cancer Center

    Kennewick, Washington, 99336

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Kinston Medical Specialists PA

    Kinston, North Carolina, 28501

  • Gundersen Lutheran

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Saint Mary Medical and Regional Cancer Center

    Langhorne, Pennsylvania, 19047

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Kansas City Cancer Center-Lee's Summit

    Lee's Summit, Missouri, 64064

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • University of Southern California/Norris Cancer Center

    Los Angeles, California, 90033

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Summa Health Center at Lake Medina

    Medina, Ohio, 44256

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

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

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Southwest General Health Center Ireland Cancer Center

    Middleburg Heights, Ohio, 44130

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Clement J. Zablocki VA Medical Center

    Milwaukee, Wisconsin, 53295

  • Memorial Medical Center

    Modesto, California, 95355

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

    Mount Holly, New Jersey, 08060

  • Skagit Valley Hospital

    Mount Vernon, Washington, 98274

  • IU Health Ball Memorial Hospital

    Muncie, Indiana, 47303

  • Intermountain Medical Center

    Murray, Utah, 84157

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Yale University

    New Haven, Connecticut, 06520

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Touro Infirmary

    New Orleans, Louisiana, 70115

  • Beth Israel Medical Center

    New York, New York, 10003

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • UMDNJ - New Jersey Medical School

    Newark, New Jersey, 07103

  • Sentara Hospitals

    Norfolk, Virginia, 23507

  • William Backus Hospital

    Norwich, Connecticut, 06360

  • Bay Area Tumor Institute CCOP

    Oakland, California, 94609

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • The Nebraska Medical Center

    Omaha, Nebraska, 68198

  • UHHS-Chagrin Highlands Medical Center

    Orange, Ohio, 44122

  • Saint Charles Hospital

    Oregon, Ohio, 43616

  • Florida Hospital

    Orlando, Florida, 32803

  • UF Cancer Center at Orlando Health

    Orlando, Florida, 32806

  • Singing River Hospital

    Pascagoula, Mississippi, 39581

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Western Oncology Research Consortium

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Portland Veterans Administration Medical Center

    Portland, Oregon, 97239

  • Cancer Centers of North Carolina

    Raleigh, North Carolina, 27607

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Robinson Radiation Oncology

    Ravenna, Ohio, 44266

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Hunter Holmes McGuire Veterans Administration Medical Center

    Richmond, Virginia, 23249

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Highland Hospital

    Rochester, New York, 14620

  • University Radiation Oncology

    Rochester, New York, 14626

  • University of Rochester

    Rochester, New York, 14642

  • Memorial Sloan-Kettering Cancer Center Rockville Centre

    Rockville Centre, New York, 11570

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • The Permanente Medical Group-Roseville Radiation Oncology

    Roseville, California, 95678

  • Texas Oncology-Seton Williamson

    Round Rock, Texas, 78665

  • Texas Oncology - Round Rock Cancer Center

    Round Rock, Texas, 78681

  • Sutter General Hospital

    Sacramento, California, 95816

  • University of California at Davis Cancer Center

    Sacramento, California, 95817

  • Mercy General Hospital Radiation Oncology Center

    Sacramento, California, 95819

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Salem Hospital

    Salem, Oregon, 97301

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Cancer Care Centers of South Texas- Northeast

    San Antonio, Texas, 78217

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • UCSF-Mount Zion

    San Francisco, California, 94115

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • Memorial Health University Medical Center

    Savannah, Georgia, 31403

  • Saint Joseph's-Candler Health System

    Savannah, Georgia, 31405

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Texas Cancer Center-Sherman

    Sherman, Texas, 75090

  • Siouxland Hematology Oncology Associates

    Sioux City, Iowa, 51101

  • Sanford Cancer Center-Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Memorial Sloan-Kettering Cancer Center at Sleepy Hallow

    Sleepy Hollow, New York, 10591

  • Sparta Cancer Treatment Center

    Sparta, New Jersey, 07871

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Greenville Health System Cancer Institute-Spartanburg

    Spartanburg, South Carolina, 29307

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Cancer Care Northwest-North Spokane

    Spokane, Washington, 99218

  • Saint John's Hospital

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis University Hospital

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Barnes-Jewish West County Hospital

    St Louis, Missouri, 63141

  • Saint John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Dixie Medical Center Regional Cancer Center

    St. George, Utah, 84770

  • Saint Helena Hospital

    St. Helena, California, 94574

  • Stanford University Hospitals and Clinics

    Stanford, California, 94305

  • Cleveland Clinic Cancer Center-Strongsville

    Strongsville, Ohio, 44136

  • Door County Cancer Center

    Sturgeon Bay, Wisconsin, 54235-1495

  • Texas Oncology Cancer Center Sugar Land

    Sugar Land, Texas, 77479

  • Flower Hospital

    Sylvania, Ohio, 43560

  • Northwest CCOP

    Tacoma, Washington, 98405

  • Arizona Oncology Associates-West Orange Grove

    Tucson, Arizona, 85704

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • 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

  • MD Anderson Cancer Center at Cooper-Voorhees

    Voorhees Township, New Jersey, 08043

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • University Pointe

    West Chester, Ohio, 45069

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145

  • Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Texas Oncology-Wichita Falls Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Cleveland Clinic Wooster Specialty Center

    Wooster, Ohio, 44691

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17405

Other trials in United States

Canada12 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

  • Ottawa Health Research Institute-General Division

    Ottawa, Ontario, K1H 1C4

  • CHUQ - Pavilion Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Doctor H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

China1 site

  • Chinese University of Hong Kong-Prince of Wales Hospital

    Shatin, Hong Kong, OX1 3UJ

Other trials in China

Saudi Arabia1 site

  • King Faisal Specialist Hospital and Research Centre

    Riyadh, 11211

Other trials in Saudi Arabia

About this study

Official title: A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective when given alone or together with cetuximab in treating patients with head and neck cancer that has been removed by surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine whether the addition of cetuximab to postoperative intensity-modulated radiotherapy (IMRT) will improve overall survival (OS) in patients with locally advanced squamous cell carcinoma of the head and neck at intermediate risk following surgery.

Secondary

  • Assess the impact of the addition of cetuximab to postoperative IMRT on disease-free survival (DFS) of these patients.
  • Assess the impact of the addition of cetuximab to postoperative IMRT on acute and late dysphagia, xerostomia, skin toxicity, and other toxicities according to common Toxicity Criteria for Adverse Effects (CTCAE), v. 4 and their relationships with patient-reported outcomes at 3, 12, and 24 months.
  • Analyze tumor for epidermal growth factor receptor (EGFR), specifically the extent of EGFR overexpression by immuno-histochemistry (IHC) and Fluorescence in situ hybridization (FISH) analysis, EGFRvIII expression, as well as the association of these assay data with OS and DFS.
  • Analyze tumor for human papillomavirus (HPV) infection (as defined by in situ hybridization), specifically, within the cohort of patients with oropharynx cancer, to perform an exploratory analysis of the impact of HPV on DFS and OS of this patient subset.
  • Analyze tumor DNA for TP53 mutations as a predictor of response to cetuximab and prognosis.
  • Analyze germline DNA of polymorphic variants in EGFR intron repeats as a predictor of response to cetuximab.

Tertiary

  • Assess the impact of the addition of cetuximab to postoperative IMRT on loco-regional control.
  • Assess the impact of the addition of cetuximab to postoperative IMRT on patient-reported quality of life, swallowing, xerostomia, and skin toxicity based on head and neck specific instruments, including the Performance Status Scale for Head and Neck Cancer (PSS-HN), the Functional Assessment of Cancer Therapy-Head \& Neck (FACT-H\&N), the University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS), and the Dermatology Life Quality Index (DLQI).
  • Assess the impact of the addition of cetuximab to postoperative IMRT on cost-utility analysis using the EuroQol (EQ-5D).
  • Evaluate the utility of image-guided radiotherapy (IGRT) as a means of enhancing the efficacy (i.e., loco-regional control) of IMRT while reducing the acute and/or late toxicity (particularly xerostomia) and improving patient-reported outcomes (particularly XeQOLS scores).
  • Retrospectively compare the loco-regional control rate in patients treated with IMRT alone (no IGRT or cetuximab) with similar patients treated with external beam radiotherapy alone in the postoperative clinical trial Radiation Therapy Oncology Group (RTOG)-95 01.

OUTLINE: This is a multicenter study. Patients are stratified according to clinical stage (T1-3 vs T4a), EGFR expression (high [≥ 80% of cells staining positive] vs low [< 80% of cells staining positive] vs not evaluable), primary site of disease (oral cavity vs larynx vs oropharynx p16+ vs oropharynx p16- vs oropharynx, p16 not evaluable), and use of image-guided radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo IMRT as in arm I. Patients also receive cetuximab IV over 1-2 hours once weekly beginning at least 5 days prior to the start of IMRT and continuing for 4 weeks after the completion of IMRT (for a total of 11 doses) in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at 3, 12, and 24 months.

Tissue samples are collected periodically for further laboratory analysis.

After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Being tested
cetuximab, intensity-modulated radiation therapy
Keywords
stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III verrucous carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, tongue cancer
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Tongue Neoplasms

What participants receive

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

  • cetuximabBiological

    intravenously

  • intensity-modulated radiation therapyRadiation

    daily fractions

Study groups in NCT00956007
Study groupRoleWhat they receive
Arm I: Intensity-Modulated RadiotherapyActive comparatorRadiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Receives: Radiation: intensity-modulated radiation therapy
Arm II: IMRT plus cetuximabExperimentalRadiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
Receives: Biological: cetuximab; Radiation: intensity-modulated radiation therapy

What is being measured

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

  1. Percentage of Participants Alive (Overall Survival)

    Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.

    Measured: From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.

Secondary outcomes (5)

  1. Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment

    Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Acute adverse events are those occurring within 90 days of the start of radiation therapy.

    Measured: From start of radiation therapy to 90 days

  2. Percentage of Participants With Other ≥ Grade 3 Adverse Events Related to Protocol Treatment

    Adverse events other than dysphagia, dermatitis radiation, and rash acneiform. Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Acute adverse events are those occurring within 90 days of the start of radiation therapy.

    Measured: From start of radiation therapy to 90 days.

  3. Percentage of Participants With ≥ Grade 3 Late Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment

    Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Late adverse events are those occurring after days from the start of radiation therapy.

    Measured: From 91 days after start of radiation therapy to date of last reported follow-up. Maximum follow-up at time of analysis was 12.1 years.

  4. Percentage of Participants With Other ≥ Grade 3 Late Adverse Events Related to Protocol Treatment

    Adverse events other than dysphagia, dermatitis radiation, and rash acneiform. Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Late adverse events are those occurring after days from the start of radiation therapy.

    Measured: From 91 days after start of radiation therapy to date of last reported follow-up. Maximum follow-up at time of analysis was 12.1 years.

  5. Disease-free Survival

    Disease is defined as local-regional progression/recurrence (LRR) or distant metastasis (DM). LRR is defined as recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; both imaging and biopsy confirmation are strongly recommended. DM is defined as clear evidence of distant metastases; biopsy is recommended where possible. Disease-free survival time is defined as time from randomization to the date of first disease, death, or last known follow-up (censored), whichever occurred first. Disease-free survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of disease-free survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.

    Measured: From randomization to date of LRR, DM, death or last known follow-up, whichever occurred first. Maximum follow-up at time of analysis was 12.1 years.

Timeline

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

  1. First posted11 Aug 2009 (estimated)
  2. Study start31 Mar 2010
  3. Primary completion5 Sep 2023
  4. Study completionAug 2029 (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
702 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00956007
Sponsor's protocol ID
RTOG 0920
Other IDs
CDR0000651536, NCI-2011-00878, 5U10CA180868
Status last verified
Jul 2025
First submitted
8 Aug 2009
Last updated
6 Jan 2026
Data monitoring committee
Yes

Publications

  • Machtay M, Torres-Saavedra PA, Thorstad W, Nguyen-Tan PF, Siu LL, Holsinger FC, El-Naggar A, Chung C, Cmelak A, Burtness B, Bednarz G, Quon H, Breen SL, Gwede CK, Dicker AP, Yao M, Jordan RC, Dorth J, Lee N, Chan JW, Dunlap N, Bar-Ad V, Stokes WA, Chakravarti A, Sher D, Rao S, Harris J, Yom SS, Le QT; NRG Oncology RTOG 0920 Collaborating Team. Postoperative Radiotherapy +/- Cetuximab for Intermediate-Risk Head and Neck Cancer. J Clin Oncol. 2025 Apr 20;43(12):1474-1487. doi: 10.1200/JCO-24-01829. Epub 2025 Jan 22.

    PubMed 39841939

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cetuximab and intensity-modulated radiation therapy in people with Head and Neck Cancer, run by Radiation Therapy Oncology Group at 264 sites in 4 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 264 sites in United States, Canada, China, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Alive (Overall Survival) (time frame: From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 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 NCT00956007, 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 6 Jan 2026.

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