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Sponsored by: |
Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021125 |
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: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have head and neck cancer.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer Non-Melanomatous Skin Cancer |
Procedure: adjuvant therapy Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Randomized Controlled Trial Of CHARTWEL (a Continuous Hyperfractionated Accelerated Radiotherapy Schedule) Versus Conventional Radiotherapy In Post-Operative Head And Neck Cancer Patients |
Estimated Enrollment: | 460 |
Study Start Date: | July 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck including, but not limited to, the following:
Undergone curative surgery within the past 70 days
At high or intermediate risk of recurrence
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United Kingdom, England | |
Mount Vernon Cancer Centre at Mount Vernon Hospital | |
Northwood, England, United Kingdom, HA6 2RN |
Study Chair: | M. I. Saunders, MD | Mount Vernon Cancer Centre at Mount Vernon Hospital |
Study ID Numbers: | CDR0000068750, MRC-CH03, EU-20121, ISRCTN62576956 |
Study First Received: | July 11, 2001 |
Last Updated: | December 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00021125 |
Health Authority: | United States: Federal Government |
squamous cell carcinoma of the skin stage I squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage I squamous cell carcinoma of the oropharynx stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx stage I squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx |
stage I squamous cell carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the paranasal sinus and nasal cavity stage II squamous cell carcinoma of the paranasal sinus and nasal cavity stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity salivary gland squamous cell carcinoma stage I salivary gland cancer stage II salivary gland cancer stage III salivary gland cancer stage IV salivary gland cancer |
Epidermoid carcinoma Skin Diseases Squamous cell carcinoma Head and Neck Neoplasms Carcinoma, squamous cell Laryngeal carcinoma |
Hypopharyngeal cancer Skin Neoplasms Carcinoma, Squamous Cell Salivary Gland Diseases Dental Caries Carcinoma |
Neoplasms Neoplasms by Site |