Clinical Trials Search
|Title||A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer|
|Trial Type||Oncology-Head and Neck|
|Trial Status||Open to Accrual|
|Principal Investigator||Marshall Levine¸ MD|
|Contact Name||Tahisa Hamwright|
Tertiary Objectives (Exploratory)
Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck (oral cavity, oropharynx or larynx); clinical stage T2-3, N0-2, M0 or T1, N1-2, M0.
3.1 Conditions for Patient Eligibility 3.1.1 Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, 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.
3.1.2 Clinical stage T1, N1-2 or T2-3, N0-2, M0 including no distant metastases, based upon the following minimum diagnostic workup:
220.127.116.11 General history and physical examination by a Radiation Oncologist and/or Medical Oncologist within 8 weeks prior to registration;
18.104.22.168 Examination by an ENT or Head & Neck Surgeon, including laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure), within 8 weeks prior to registration;
22.214.171.124 Chest x-ray (at a minimum) or chest CT scan (with or without contrast) or CT/PET of chest (with or without contrast) within 8 weeks prior to registration.
3.1.3 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:
126.96.36.199 Perineural invasion;
188.8.131.52 Lymphovascular invasion;
184.108.40.206 Single lymph node > 3 cm or ≥ 2 lymph nodes (all < 6 cm) [no extracapsular extension];
220.127.116.11 Close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin;
18.104.22.168 T3 or microscopic T4a primary tumor (Note: Gross T4a or T4b is ineligible);
22.214.171.124 T2 oral cavity cancer with > 5 mm depth of invasion.
3.1.4 Zubrod Performance Status of 0-1 within 2 weeks prior to registration;
3.1.5 Age ≥ 18; 3.1.6 CBC/differential obtained within 4 weeks prior to registration on study, with adequate bone marrow function defined as follows: 126.96.36.199 Absolute granulocyte count (AGC) ≥ 1,500 cells/mm3;
188.8.131.52 Platelets ≥ 100,000 cells/mm3; RTOG 0920 18
184.108.40.206 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable).
3.1.7 Adequate hepatic function, defined as follows:
220.127.116.11 Total bilirubin < 2 x institutional ULN within 2 weeks prior to registration;
18.104.22.168 AST or ALT < 3 x institutional ULN within 2 weeks prior to registration.
3.1.8 Adequate renal function, defined as follows:
22.214.171.124 Serum creatinine < 2 x institutional ULN within 2 weeks prior to registration or; creatinine clearance (CC) ≥ 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 (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male)
3.1.9 Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential;
3.1.10 (6/4/10) 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.
3.1.11 Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control; 3.1.12 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.
3.2.1 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.
3.2.2 Per the operative 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;
3.2.3 Prior systemic chemotherapy or anti-EGF therapy for the study cancer; note: prior chemotherapy or anti-EGF therapy for a different cancer is allowable. See section 3.2.1.
3.2.4 Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
3.2.5 Severe, active co-morbidity, defined as follows:
126.96.36.199 Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration;
188.8.131.52 Transmural myocardial infarction within 6 months prior to registration;
184.108.40.206 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
220.127.116.11 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
18.104.22.168 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;
22.214.171.124 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.
126.96.36.199 Acquired Immune Deficiency Syndrome (AIDS) based upon current 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.
188.8.131.52 (6/4/10) Grade 3-4 electrolyte abnormalities (CTCAE, v. 4.0):