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Radiation Therapy in Treating Patients With Head and Neck Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Radiation Therapy in Treating Patients With Head and Neck Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Radiation Therapy in Treating Patients With Head and Neck Cancer Clinical research trials and 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 evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Radiation Therapy in Treating Patients With Head and Neck Cancer. Radiation Therapy in Treating Patients With Head and Neck Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Radiation Therapy in Treating Patients With Head and Neck Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Radiation Therapy in Treating Patients With Head and Neck Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy in Treating Patients With Head and Neck Cancer  Radiation Therapy in Treating Patients With Head and Neck Cancer
Radiation Therapy in Treating Patients With Head and Neck Cancer
For Condition: skin tumor,Head and Neck Cancer
Status: Recruiting
Sponsor(s): Medical Research Council ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for head and neck cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have head and neck cancer.
Details: OBJECTIVES: - Compare adjuvant continuous hyperfractionated accelerated radiotherapy vs conventional radiotherapy, in terms of preventing disease recurrence, in patients with head and neck cancer. - Compare the early and late toxic effects of these treatments in this patient population. - Compare disease-free and overall survival of patients receiving these treatments. - Assess quality of life in patients receiving these treatments. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. - Arm I: Patients undergo radiotherapy 3 times daily, with an interval of at least 6 hours between any 2 treatments, 5 days a week, for just over 2 weeks, for a total of 13-14 treatment days. - Arm II: Patients undergo radiotherapy daily, 5 days a week, for 6-6.5 weeks. Quality of life is assessed at baseline and then annually for 5 years. Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 460 patients (230 per arm) will be accrued for this study within 2-3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the head and neck including, but not limited to, the following: - Oral cavity - Oropharynx - Hypopharynx - Larynx - Nasal sinuses - Skin - Undergone curative surgery within the past 70 days - All macroscopic disease removed - At high or intermediate risk of recurrence - No low risk of recurrence - No evidence of distant metastases - Considered treatable by radiotherapy PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No other prior or concurrent malignancy that would preclude study participation - No other uncontrolled medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
M.I.Saunders, Study Chair, Mount Vernon Hospital
Mount Vernon Hospital *Recruiting*
Northwood, England, HA6 2RN
United Kingdom
Recruiting M.I. Saunders 44-1923-844-533
Additional Information:
Study ID Numbers: CDR0000068750; EU-20121,MRC-CH03,ISRCTN-62576956
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021125
Other Head And Neck Cancer Studies:
1. Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
2. OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer
3. Comparison of Gene Therapy With Chemotherapy in Treating Patients With Head and Neck Cancer
4. Flavopiridol for Treating Recurrent or Metastatic Head and Neck Cancer
5. Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other England Clinical Trials
Other Northwood Clinical Trials
Radiation Therapy in Treating Patients With Head and Neck Cancer
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