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| Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006051 |
Purpose
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 | Intervention | Phase |
|
Head and Neck Cancer |
Drug: cisplatin Drug: fluorouracil Procedure: radiation therapy |
Phase II |
| MedlinePlus related topics: | Cancer Head and Neck Cancer |
| ChemIDplus related topics: | Cisplatin Fluorouracil |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Combination Chemotherapy Concurrent With Postoperative Radiotherapy Epidermoid Carcinoma of the Head and Neck at High Risk of Recurrence - Study of Feasibility |
| Study Start Date: | February 1999 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |||||
| Centre Alexis Vautrin | |||||
| Vandoeuvre-les-Nancy, France, 54511 | |||||
| Centre Hospitalier Universitaire Bretonneau de Tours | |||||
| Tours, France, 37044 | |||||
| Centre Jean Perrin | |||||
| Clermont-Ferrand, France, 63011 | |||||
| Institut Gustave Roussy | |||||
| Villejuif, France, F-94805 | |||||
| Hopital Jean Monnet | |||||
| Epinal, France, 88021 | |||||
| CRLCC Nantes - Atlantique | |||||
| Nantes-Saint Herblain, France, 44805 | |||||
| Federation Nationale des Centres de Lutte Contre le Cancer |
| Study Chair: | Lionnel Geoffrois, MD | Centre Alexis Vautrin |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
|
| Study ID Numbers: | CDR0000068073, FRE-FNCLCC-GORTEC98-01/98007, EU-20015 |
| First Received: | July 5, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006051 |
| Health Authority: | United States: Federal Government |
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