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NCT00006051 Clinical Trial

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Combination Chemotherapy Concurrent With Postoperative Radiotherapy Epidermoid Carcinoma of the Head and Neck at High Risk of Recurrence - Study of Feasibility

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00006051
Other study ID # CDR0000068073
Secondary ID FRE-FNCLCC-GORTE
Status Completed
Phase Phase 2
First received
Last updated
Start date February 1999
Est. completion date September 2005

Study information
Verified date February 2021
Source UNICANCER
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date September 2005
Est. primary completion date August 2002
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 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 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• cisplatin

• fluorouracil

Radiation:
• radiation therapy

Locations
Country Name City State
France Centre Jean Perrin Clermont-Ferrand
France Hopital Jean Monnet Epinal
France CRLCC Nantes - Atlantique Nantes-Saint Herblain
France Centre Hospitalier Universitaire Bretonneau de Tours Tours
France Centre Alexis Vautrin Vandoeuvre-les-Nancy
France Institut Gustave Roussy Villejuif

Sponsors (1)
Lead Sponsor Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

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