Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT00956007

PHASE3

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

Sponsor: Radiation Therapy Oncology Group

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

702

Start Date

2010-03-31

Completion Date

2029-08

Last Updated

2026-01-06

Healthy Volunteers

Conditions

Head and Neck Cancer

Interventions

BIOLOGICAL

cetuximab

intravenously

RADIATION

intensity-modulated radiation therapy

daily fractions

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.

Locations (264)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arizona Oncology Associates-West Orange Grove

Tucson, Arizona, United States

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

City of Hope

Duarte, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Los Angeles County-USC Medical Center

Los Angeles, California, United States

University of Southern California/Norris Cancer Center

Los Angeles, California, United States

Memorial Medical Center

Modesto, California, United States

Bay Area Tumor Institute CCOP

Oakland, California, United States

Pomona Valley Hospital Medical Center

Pomona, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Sutter General Hospital

Sacramento, California, United States

University of California at Davis Cancer Center

Sacramento, California, United States

Mercy General Hospital Radiation Oncology Center

Sacramento, California, United States

UCSF-Mount Zion

San Francisco, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Saint Helena Hospital

St. Helena, California, United States

Stanford University Hospitals and Clinics

Stanford, California, United States

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Saint Vincent's Medical Center

Bridgeport, Connecticut, United States

Yale University

New Haven, Connecticut, United States

William Backus Hospital

Norwich, Connecticut, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

Florida Hospital

Orlando, Florida, United States

UF Cancer Center at Orlando Health

Orlando, Florida, United States

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Saint Joseph's-Candler Health System

Savannah, Georgia, United States

Queen's Medical Center

Honolulu, Hawaii, United States

University of Hawaii

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Hines Veterans Administration Hospital

Hines, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Saint John's Hospital

Springfield, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Radiation Oncology Associates PC

Fort Wayne, Indiana, United States

Parkview Hospital Randallia

Fort Wayne, Indiana, United States

IU Health Methodist Hospital

Indianapolis, Indiana, United States

Community Regional Cancer Care-East Radiation Oncology

Indianapolis, Indiana, United States

Community Regional Cancer Care-North

Indianapolis, Indiana, United States

IU Health Ball Memorial Hospital

Muncie, Indiana, United States

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Siouxland Hematology Oncology Associates

Sioux City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Touro Infirmary

New Orleans, Louisiana, United States

Central Maine Medical Center

Lewiston, Maine, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Peninsula Regional Medical Center

Salisbury, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

University of Michigan

Ann Arbor, Michigan, United States

Oakwood Hospital

Dearborn, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Saint John Hospital and Medical Center

Detroit, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Saint Mary's of Michigan

Saginaw, Michigan, United States

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Saint Luke's Hospital of Duluth

Duluth, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Singing River Hospital

Pascagoula, Mississippi, United States

Cape Radiation Oncology

Cape Girardeau, Missouri, United States

Siteman Cancer Center - Saint Peters

City of Saint Peters, Missouri, United States

University of Missouri - Ellis Fischel

Columbia, Missouri, United States

Kansas City Cancer Centers - North

Kansas City, Missouri, United States

Kansas City Cancer Center-Lee's Summit

Lee's Summit, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

CoxHealth South Hospital

Springfield, Missouri, United States

Saint Louis University Hospital