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Clinical Trials in Ireland / NCT00956007
Active, not recruiting Phase 3

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

NCT00956007 · tracked via the Priya Life Science Ireland tracker
Sponsor
Radiation Therapy Oncology Group
Phase
Phase 3
Started
2010-03-31
Last updated
2026-01-06

Condition(s) studied

Head and Neck Cancer

Investigational drug(s) / intervention(s)

cetuximabintensity-modulated radiation therapy

cetuximab: intravenously

intensity-modulated radiation therapy: daily fractions

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (264)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Arizona Oncology Associates-West Orange Grove Tucson Arizona
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
Mercy San Juan Medical Center Carmichael California
City of Hope Duarte California
UC San Diego Moores Cancer Center La Jolla California
Kaiser Permanente Los Angeles Medical Center Los Angeles California
Los Angeles County-USC Medical Center Los Angeles California
University of Southern California/Norris Cancer Center Los Angeles California
Memorial Medical Center Modesto California
Bay Area Tumor Institute CCOP Oakland California
Pomona Valley Hospital Medical Center Pomona California
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
The Permanente Medical Group-Roseville Radiation Oncology Roseville California
Sutter General Hospital Sacramento California
University of California at Davis Cancer Center Sacramento California
Mercy General Hospital Radiation Oncology Center Sacramento California
UCSF-Mount Zion San Francisco California
Kaiser Permanente Medical Center - Santa Clara Santa Clara California
Saint Helena Hospital St. Helena California
Stanford University Hospitals and Clinics Stanford California
Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California
Rocky Mountain Cancer Centers-Aurora Aurora Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora Colorado
Penrose-Saint Francis Healthcare Colorado Springs Colorado
Porter Adventist Hospital Denver Colorado
Swedish Medical Center Englewood Colorado
Rocky Mountain Cancer Centers-Littleton Littleton Colorado
Saint Vincent's Medical Center Bridgeport Connecticut
Yale University New Haven Connecticut
William Backus Hospital Norwich Connecticut
Christiana Care Health System-Christiana Hospital Newark Delaware
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
Mayo Clinic in Florida Jacksonville Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
Baptist Hospital of Miami Miami Florida
Florida Hospital Orlando Florida
UF Cancer Center at Orlando Health Orlando Florida
Emory University/Winship Cancer Institute Atlanta Georgia

+ 224 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00956007 on ClinicalTrials.gov ↗ ← All trials in Ireland