ICH GCP | Clinical Trials Registry

Eastern Cooperative Oncology Group 

National Cancer Institute (NCI) 

Yes

Yes

No

DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the head and neck - Primary site must be within the oral cavity, oropharynx, larynx, or hypopharynx - Stage III or IV primary lesion at diagnosis - No distant metastatic disease at diagnosis - No multiple primary lesions - Currently disease-free after treatment with 1 of the following: - Complete tumor resection - Radiotherapy or chemoradiotherapy alone* - Resection followed by radiotherapy/chemoradiotherapy* - No more than 4-16 weeks since prior surgery and/or radiotherapy/chemoradiotherapy NOTE: *Radiotherapy must have been 70-72 Gy in 1.8-2.0 Gy fractions to the primary tumor and clinically positive neck nodes and 44-50 Gy in 1.8-2.0 Gy fractions to clinically negative nodes, including the lower neck PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - AST and ALT no greater than 2 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2 times ULN Renal - Creatinine no greater than 1.2 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for 1 month prior to, during, and for 1 month after study therapy - Electrolytes normal - Fasting serum triglyceride level no greater than 2 times ULN (anti-triglyceride medication allowed) - No other malignancy within the past 2 years except localized basal cell or squamous cell skin cancer - No other concurrent medical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy and recovered - Prior neoadjuvant chemotherapy allowed - Prior chemotherapy administered concurrently with radiotherapy allowed - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - Recovered from prior radiotherapy Surgery - See Disease Characteristics - Recovered from prior surgery Other - No history of megadose vitamin A (more than 25,000 I.U.) - No other clinical trial enrollment that would preclude adjuvant systemic therapy - No concurrent vitamin supplements containing vitamin A

All

18 Years

120 Years

No

Randomized

Treatment