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Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer Clinical research trials and Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer. Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer  Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer
Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer
For Condition: Throat Cancer,Oral Cancer
Status: No longer recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LionnelGeoffrois, Study Chair, Federation Nationale des Centres de Lutte Contre le Cancer
Hopital Jean Monnet
Epinal, , 88021
France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Institut Gustave Roussy
Villejuif, , F-94805
France
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, , 54511
France
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , 37044
France
Additional Information:
Study ID Numbers: CDR0000068073; FRE-FNCLCC-GORTEC98-01/98007,EU-20015
Study Start Date: February 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006051
Other Throat Cancer Studies:
1. Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
2. Radiation Therapy, Combination Chemotherapy, and Amifostine in Treating Patients With Head and Neck Cancer
3. Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer
5. ZD1839 in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck
Related Studies:
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Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer
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