放射治療聯合或不聯合Cetuximab治療曾接受手術的局部晚期頭頸癌患者

納入條件

• 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cancer extending to within 5 mm of a surgical margin, and/or an initially focally positive margin that is subsequently superseded by intraoperative negative margins.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