RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have head and neck cancer.

Condition	Treatment or Intervention	Phase
Throat Cancer Oral Cancer	Drug: cisplatin  Drug: fluorouracil	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the toxicity of fluorouracil and cisplatin with concurrent radiotherapy in patients with stage I-IVB squamous cell cancer of the head and neck at high risk of recurrence following curative resection. II. Determine the efficacy of this regimen in these patients. III. Determine the survival of these patients treated with this regimen.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive fluorouracil IV continuously on days 1-5 and 43-47 and cisplatin IV over 1 hour on days 2, 23, and 44. Concurrent radiotherapy is administered 5 days a week for 6.5 weeks. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 44-68 patients will be accrued for this study within 18 months.

Ages Eligible for Study:  18 Years   -   70 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven stage I-IVB squamous cell cancer of the oral cavity, oropharynx, hypopharynx, or larynx; Positive lymph nodes allowed, either bilateral or contralateral
• Curatively resected within past 6 weeks
• No distant metastases

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy
• Surgery: See Disease Characteristics
• Other: No other concurrent adjuvant therapy; No concurrent preventive treatment (e.g., retinoids); No other concurrent experimental treatment

--Patient Characteristics--

• Age: Over 18 to 70
• Performance status: Karnofsky 70-100%
• Life expectancy: Not specified
• Hematopoietic: WBC at least 2,000/mm3; Platelet count at least 150,000/mm3
• Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); SGOT and SGPT less than 2 times ULN; Alkaline phosphatase less than 2 times ULN
• Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 70 mL/min
• Cardiovascular: No contraindication to fluorouracil IV; No coronary artery disease greater than grade 2; No unstable heart disease
• Other: No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix; Not pregnant; Fertile patients must use effective contraception

France
      Centre Alexis Vautrin, Vandoeuvre-les-Nancy,  54511,  France
      Centre Hospitalier Universitaire Bretonneau de Tours, Tours,  37044,  France
      Centre Jean Perrin, Clermont-Ferrand,  63011,  France
      CRLCC Nantes - Atlantique, Nantes-Saint Herblain,  44805,  France
      Hopital Jean Monnet, Epinal,  88021,  France
      Institut Gustave Roussy, Villejuif,  F-94805,  France

Study chairs or principal investigators

Lionnel Geoffrois,  Study Chair,  Federation Nationale des Centres de Lutte Contre le Cancer   

Study ID Numbers:  CDR0000068073; FRE-FNCLCC-GORTEC98-01/98007; EU-20015
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00006051
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08