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

NCT00956007 | Active Not Recruiting Phase 3 Results DMC

• 4 other identifiers: RTOG 0920CDR0000651536NCI-2011-008785U10CA180868
• Study Type: interventional
• Target: 702
• Locations: 4 countries
• Sites: 264

Brief 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. 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.

Conditions

Head and Neck Cancer

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

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

  From start of radiation therapy to 90 days

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

  From start of radiation therapy to 90 days.

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

  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.

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

  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.

• Disease-free Survival

  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.

Other Outcomes (8)

• Xerostomia as Measured by University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS) at Baseline and at 3, 12, and 24 Months

  From randomization to 2 years.

• Swallowing as Measured by the Normalcy of Diet Subscale of the Performance Status Scale for Head and Neck Cancer (PSS-HN) at Baseline and at 3, 12, and 24 Months

  From randomization to 2 years.

• Skin Toxicity as Measured by the Dermatology Life Quality Index (DLQI) at Baseline and at 3, 12, and 24 Months

  From randomization to 2 years.

Study Arms (2)

Arm I: Intensity-Modulated Radiotherapy

ACTIVE COMPARATOR

Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).

Radiation: intensity-modulated radiation therapy

Arm II: IMRT plus cetuximab

EXPERIMENTAL

Radiation 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.

Biological: cetuximab; Radiation: intensity-modulated radiation therapy

Interventions

cetuximab BIOLOGICAL

intravenously

Arm II: IMRT plus cetuximab

intensity-modulated radiation therapy RADIATION

daily fractions

Arm I: Intensity-Modulated Radiotherapy; Arm II: IMRT plus cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (264)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Oncology Associates-West Orange Grove

Tucson, Arizona, 85704, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, 95603, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, 95682, United States

Location

Mercy San Juan Medical Center

Carmichael, California, 95608, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

University of Southern California/Norris Cancer Center

Los Angeles, California, 90033, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

Bay Area Tumor Institute CCOP

Oakland, California, 94609, United States

Location

Pomona Valley Hospital Medical Center

Pomona, California, 91767, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States

Location

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, 95678, United States

Location

Sutter General Hospital

Sacramento, California, 95816, United States

Location

University of California at Davis Cancer Center

Sacramento, California, 95817, United States

Location

Mercy General Hospital Radiation Oncology Center

Sacramento, California, 95819, United States

Location

UCSF-Mount Zion

San Francisco, California, 94115, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

Saint Helena Hospital

St. Helena, California, 94574, United States

Location

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, 95687, United States

Location

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, 80012, United States

Location

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, 80120, United States

Location

Saint Vincent's Medical Center

Bridgeport, Connecticut, 06606, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

William Backus Hospital

Norwich, Connecticut, 06360, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

UF Cancer Center at Orlando Health

Orlando, Florida, 32806, United States

Location

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31403, United States

Location

Saint Joseph's-Candler Health System

Savannah, Georgia, 31405, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

University of Hawaii

Honolulu, Hawaii, 96813, United States

Location

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, 96817, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612-3785, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Hines Veterans Administration Hospital

Hines, Illinois, 60141, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Saint John's Hospital

Springfield, Illinois, 62702, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Radiation Oncology Associates PC

Fort Wayne, Indiana, 46804, United States

Location

Parkview Hospital Randallia

Fort Wayne, Indiana, 46805, United States

Location

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Community Regional Cancer Care-East Radiation Oncology

Indianapolis, Indiana, 46219, United States

Location

Community Regional Cancer Care-North

Indianapolis, Indiana, 46256, United States

Location

IU Health Ball Memorial Hospital

Muncie, Indiana, 47303, United States

Location

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, 50010, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Siouxland Hematology Oncology Associates

Sioux City, Iowa, 51101, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Touro Infirmary

New Orleans, Louisiana, 70115, United States

Location

Central Maine Medical Center

Lewiston, Maine, 04240, United States

Location

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Oakwood Hospital

Dearborn, Michigan, 48124, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Saint John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Saint Mary's of Michigan

Saginaw, Michigan, 48601, United States

Location

Saint John Macomb-Oakland Hospital

Warren, Michigan, 48093, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Saint Luke's Hospital of Duluth

Duluth, Minnesota, 55805, United States

Location

Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Cape Radiation Oncology

Cape Girardeau, Missouri, 63703, United States

Location

Siteman Cancer Center - Saint Peters

City of Saint Peters, Missouri, 63376, United States

Location

University of Missouri - Ellis Fischel

Columbia, Missouri, 65212, United States

Location

Kansas City Cancer Centers - North

Kansas City, Missouri, 64154, United States

Location

Kansas City Cancer Center-Lee's Summit

Lee's Summit, Missouri, 64064, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Barnes-Jewish West County Hospital

St Louis, Missouri, 63141, United States

Location

Saint John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Saint Elizabeth Regional Medical Center

Lincoln, Nebraska, 68510, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

The Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Exeter Hospital

Exeter, New Hampshire, 03833, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Memorial Sloan Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

Mount Holly, New Jersey, 08060, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

UMDNJ - New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Sparta Cancer Treatment Center

Sparta, New Jersey, 07871, United States

Location

MD Anderson Cancer Center at Cooper-Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

New York Oncology Hematology PC - Albany

Albany, New York, 12206, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Sands Cancer Center

Canandaigua, New York, 14424, United States

Location

Memorial Sloan Kettering Cancer Center Commack

Commack, New York, 11725, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Highland Hospital

Rochester, New York, 14620, United States

Location

University Radiation Oncology

Rochester, New York, 14626, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Memorial Sloan-Kettering Cancer Center Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan-Kettering Cancer Center at Sleepy Hallow

Sleepy Hollow, New York, 10591, United States

Location

Mission Hospital-Memorial Campus

Asheville, North Carolina, 28801, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Kinston Medical Specialists PA

Kinston, North Carolina, 28501, United States

Location

Cancer Centers of North Carolina

Raleigh, North Carolina, 27607, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

Summa Akron City Hospital/Cooper Cancer Center

Akron, Ohio, 44304, United States

Location

Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Summa Barberton Hospital

Barberton, Ohio, 44203, United States

Location

Mercy Medical Center

Canton, Ohio, 44708, United States

Location

Geaugra Hospital

Chardon, Ohio, 44024, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Mercy Cancer Center-Elyria

Elyria, Ohio, 44035, United States

Location

Cleveland Clinic Cancer Center Independence

Independence, Ohio, 44131, United States

Location

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States

Location

Summa Health Center at Lake Medina

Medina, Ohio, 44256, United States

Location

Lake University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

Southwest General Health Center Ireland Cancer Center

Middleburg Heights, Ohio, 44130, United States

Location

UHHS-Chagrin Highlands Medical Center

Orange, Ohio, 44122, United States

Location

Saint Charles Hospital

Oregon, Ohio, 43616, United States

Location

Robinson Radiation Oncology

Ravenna, Ohio, 44266, United States

Location

North Coast Cancer Care

Sandusky, Ohio, 44870, United States

Location

Cleveland Clinic Cancer Center-Strongsville

Strongsville, Ohio, 44136, United States

Location

Flower Hospital

Sylvania, Ohio, 43560, United States

Location

University Pointe

West Chester, Ohio, 45069, United States

Location

UHHS-Westlake Medical Center

Westlake, Ohio, 44145, United States

Location

Cleveland Clinic Wooster Specialty Center

Wooster, Ohio, 44691, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015, United States

Location

Willamette Valley Cancer Center

Eugene, Oregon, 97401, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Western Oncology Research Consortium

Portland, Oregon, 97213, United States

Location

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Portland Veterans Administration Medical Center

Portland, Oregon, 97239, United States

Location

Salem Hospital

Salem, Oregon, 97301, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18105, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, 18512, United States

Location

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301, United States

Location

Adams Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Cherry Tree Cancer Center

Hanover, Pennsylvania, 17331, United States

Location

Saint Mary Medical and Regional Cancer Center

Langhorne, Pennsylvania, 19047, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

WellSpan Health-York Hospital

York, Pennsylvania, 17405, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute/Greenville CCOP

Greenville, South Carolina, 29615, United States

Location

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Sanford Cancer Center-Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Wellmont Holston Valley Hospital and Medical Center

Kingsport, Tennessee, 37660, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Texas Oncology-Austin Midtown

Austin, Texas, 78705, United States

Location

Texas Oncology - Central Austin Cancer Center

Austin, Texas, 78731, United States

Location

Texas Oncology - South Austin Cancer Center

Austin, Texas, 78745, United States

Location

Texas Oncology PA - Bedford

Bedford, Texas, 76022, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Texas Oncology-Denton South

Denton, Texas, 76210, United States

Location

The Klabzuba Cancer Center

Fort Worth, Texas, 76104, United States

Location

Memorial Hermann Memorial City Medical Center

Houston, Texas, 77024, United States

Location

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Texas Oncology-Seton Williamson

Round Rock, Texas, 78665, United States

Location

Texas Oncology - Round Rock Cancer Center

Round Rock, Texas, 78681, United States

Location

Cancer Care Centers of South Texas- Northeast

San Antonio, Texas, 78217, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Texas Cancer Center-Sherman

Sherman, Texas, 75090, United States

Location

Texas Oncology Cancer Center Sugar Land

Sugar Land, Texas, 77479, United States

Location

Texas Oncology-Wichita Falls Texoma Cancer Center

Wichita Falls, Texas, 76310, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, 84106, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Medical Center Regional Cancer Center

St. George, Utah, 84770, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Sentara Cancer Institute at Sentara CarePlex Hospital

Hampton, Virginia, 23666, United States

Location

Sentara Hospitals

Norfolk, Virginia, 23507, United States

Location

Hunter Holmes McGuire Veterans Administration Medical Center

Richmond, Virginia, 23249, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Sentara Virginia Beach General Hospital

Virginia Beach, Virginia, 23454, United States

Location

Harrison Medical Center

Bremerton, Washington, 98310, United States

Location

Tri-Cities Cancer Center

Kennewick, Washington, 99336, United States

Location

Skagit Valley Hospital

Mount Vernon, Washington, 98274, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Cancer Care Northwest-North Spokane

Spokane, Washington, 99218, United States

Location

Northwest CCOP

Tacoma, Washington, 98405, United States

Location

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664, United States

Location

Compass Oncology Vancouver

Vancouver, Washington, 98684, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801, United States

Location

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

Location

Wheeling Hospital

Wheeling, West Virginia, 26003, United States

Location

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409, United States

Location

Fox Valley Hematology and Oncology

Appleton, Wisconsin, 54911-3496, United States

Location

Saint Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

Gundersen Lutheran

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Clement J. Zablocki VA Medical Center

Milwaukee, Wisconsin, 53295, United States

Location

Door County Cancer Center

Sturgeon Bay, Wisconsin, 54235-1495, United States

Location

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Doctor H. Bliss Murphy Cancer Centre

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

Location

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Health Research Institute-General Division

Ottawa, Ontario, K1H 1C4, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University Department of Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

CHUQ - Pavilion Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Chinese University of Hong Kong-Prince of Wales Hospital

Shatin, Hong Kong, OX1 3UJ, China

Location

King Faisal Specialist Hospital and Research Centre

Riyadh, 11211, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 39841939 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms

Interventions

Cetuximab; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Limitations and Caveats

Due to a lower-than-expected death rate, the statistical design was modified to perform the primary analysis after all randomized patients had a minimum of 5 years of potential follow-up.

Results Point of Contact

• Title: Wendy Seiferheld
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

2155743208

Study Officials

• Mitchell Machtay, MD

  Milton S. Hershey Medical Center, Penn State Health

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2009
• First Posted: August 11, 2009
• Study Start: March 31, 2010
• Primary Completion: September 5, 2023
• Study Completion (Estimated): August 1, 2029
• Last Updated: January 6, 2026
• Results First Posted: May 28, 2024

Record last verified: 2025-07

Locations

SA (1); US (250); CN (1); CA (12)