Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
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 oropharynx, stage IV squamous cell carcinoma of the oropharynx, 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
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven locally advanced squamous cell carcinoma of the head and neck Stage III or IV without distant metastases Unresectable Primary tumor sites: Oral cavity Oropharynx Hypopharynx Larynx Must have at least one measurable lesion PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT and SGPT no greater than 2.5 times ULN Alkaline phosphatase no greater than 5 times ULN No SGOT and SGPT greater than 1.5 times ULN AND alkaline phosphatase greater than 2.5 times ULN Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: At least 6 months since prior myocardial infarction No unstable, treated cardiac disease Pulmonary: At least one year since prior hospitalization for chronic obstructive pulmonary disease Neurologic: No neurologic or psychiatric disorders (e.g., dementia or seizures) No concurrent peripheral neuropathy greater than grade 1 Other: No active uncontrolled infection No active peptic ulcer No alteration in hearing At least 5 years since any other neoplastic disease except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer curatively treated by surgery Not pregnant or nursing Fertile patients must use effective contraception No other psychological, familial, sociological, or geographical condition that would prevent compliance PRIOR CONCURRENT THERAPY: Biologic therapy: No primary prophylactic colony stimulating factors during the first course of therapy Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior corticosteroid No chronic corticosteroid therapy (greater than 3 months) Radiotherapy: No prior radiotherapy Surgery: No prior surgery for this cancer Other: At least 30 days since prior treatment in a clinical trial No concurrent use of drugs that interact with fluorouracil (e.g., cimetidine, allopurinol, folic acid or leucovorin calcium) No other concurrent investigational drugs or anticancer treatment
Sites / Locations
- Landeskrankenhaus/Universitatskliniken Graz
- Allgemeines Krankenhaus der Stadt Wien
- Kaiser Franz Josef Hospital
- Algemeen Ziekenhuis Middelheim
- Institut Jules Bordet
- Universitair Ziekenhuis Antwerpen
- Centre Hospitalier Regional de la Citadelle
- Clinique Universitaire De Mont-Godinne
- Institute of Oncology and Radiology of Serbia
- CHR de Besancon - Hopital Jean Minjoz
- Centre Oscar Lambret
- Centre Hospital Regional Universitaire de Limoges
- Centre Leon Berard
- CRLCC Nantes - Atlantique
- CHR Hotel Dieu
- Centre Antoine Lacassagne
- Martin Luther Universitaet
- Caritasklinik St. Theresia
- Mutterhaus der Borromaerinnen
- Ahepa University Hospital
- National Institute of Oncology
- Szent Margit Hospital
- Borsod-Abauj-Zemplen County Hospital
- Centro di Riferimento Oncologico - Aviano
- Ospedale Santa Croce
- Istituti Fisioterapici Ospitalieri - Roma
- Ospedale di Circolo e Fondazione Macchi
- Academisch Medisch Centrum
- Leiden University Medical Center
- Academisch Ziekenhuis Maastricht
- University Medical Center Nijmegen
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
- National Cancer Institute - Bratislava
- Institut Catala d'Oncologia - Hospital Duran i Reynals
- Hospital General de Jerez
- Universidad de Santiago - Hospital de Conxo
- Hospital Clinico Universitario de Valencia
- Kantonspital Aarau
- Ospedale San Giovanni
- Istanbul University-Institute of Oncology
- Charing Cross Hospital
- Middlesex Hospital- Meyerstein Institute
- Newcastle General Hospital
- Beatson Oncology Centre