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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 certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Radiation Therapy in Treating Patients With Head and Neck Cancer conditions. Clinical Trials Search.org is a website committed 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 health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like 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 allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Radiation Therapy in Treating Patients With Head and Neck Cancer clinical trial. Subjects frequently get the best healthcare possible for their Radiation Therapy in Treating Patients With Head and Neck Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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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. Boronophenylalanine-Fructose Complex (BPA-F) and/or Sodium Borocaptate (BSH) Followed By Surgery in Treating Patients With Thyroid Cancer, Head and Neck Cancer, or Liver Metastases
2. Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
3. Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer
4. Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
5. Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage 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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