S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer (S0217)
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III salivary gland cancer, stage IV salivary gland cancer, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, salivary gland squamous cell carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of squamous cell carcinoma of the head and neck Selected stage III or IV (no distant metastasis) disease The following TNM stages are excluded: T3, N0, M0 T4a, N0, M0 T4b, N3, M0 Any T, any N, M1 Complete total resection within the past 56 days AND has one or more of the following risk factors: Multiple pathologically confirmed lymph node metastases One or more lymph nodes with extracapsular extension of tumor Microscopically positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection No primary nasopharyngeal carcinoma PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL Hepatic Bilirubin ≤ 2 times upper limit of normal (ULN) SGOT or SGPT ≤ 1.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 mg/dL OR Creatinine clearance ≥ 60 mL/min Other No pre-existing peripheral neuropathy No known history of severe hypersensitiviy reaction to products containing Polysorbate 80 No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for the malignancy Endocrine therapy Not specified Radiotherapy No prior radiotherapy for the malignancy Surgery See Disease Characteristics Other No concurrent amifostine
Sites / Locations
- USC/Norris Comprehensive Cancer Center and Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Regional Cancer Center at Memorial Medical Center
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- University of Michigan Comprehensive Cancer Center
- University of Mississippi Medical Center
- Saint Louis University Cancer Center
- Rutherford Hospital
- Adena Regional Medical Center
- Cleveland Clinic Taussig Cancer Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Riverside Cancer Services
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grady Memorial Hospital
- Community Oncology Group at Cleveland Clinic Cancer Center
- Fairfield Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Mercy Medical Center
- Community Hospital of Springfield and Clark County
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
- Cleveland Clinic - Wooster
- Genesis - Good Samaritan Hospital
- AnMed Health Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Arms of the Study
Arm 1
Experimental
chemoRT after surgery
chemoRT with cisplatin and docetaxel after surgery