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Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer Clinical research trials and Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer. Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer  Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
For Condition: Gastrointestinal Cancer,Throat Cancer,Oral Cancer,Neck Cancer
Status: No longer recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
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 radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with head and neck cancer.
Details: OBJECTIVES: - Determine the locoregional control rates, time to failure, need for salvage surgery and overall survival of patients with intermediate stage cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus. - Measure the impact of concomitant Hyper-FHX radiotherapy on organ preservation, organ function and quality of life parameters. - Identify possible prognostic factors for toxic effects and response by performing pharmacologic monitoring. OUTLINE: Patients receive concomitant chemoradiotherapy with curative intent. Patients who have microscopic or macroscopic residual disease 6 weeks after completion of chemoradiotherapy will receive a surgical salvage procedure. The first cycle of chemotherapy will begin with PO doses of hydroxyurea every 12 hours on days 0-5. Fluorouracil is given IV on days 0-4. Radiation therapy BID is given on days 1-6. Cycles repeat every 14 days for a total of 5 cycles. The disease will be reevaluated 4-6 weeks after completion of all treatment, every 3 months for 1 year, then yearly. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed diagnosis of carcinoma - Stage II-III (T2, T3, N0 or T1-3, N1) carcinoma of head and neck, including: oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus - No N2 or N3 - Measurable disease is not required PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0-3 Life expectancy: - Anticipated survival is 3-4 years (median) Hematopoietic: - WBC count at least 3.5/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Not specified Renal: - Not specified Cardiovascular: - Not specified Pulmonary: - Not specified Other: - No infection or severe medical illness - Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - No prior surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EverettVokes, Study Chair, University of Chicago Cancer Research Center
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
Additional Information:
Study ID Numbers: CDR0000065421; UCCRC-8176,NU-V96N1,NCI-G97-1159
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002951
Other Neck Cancer Studies:
1. Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx
2. Chemotherapy in Treating Patients With Solid Tumors
3. Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
4. 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:
Other Neck Cancer Clinical Trials
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Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
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