Head and Neck Cancer Clinical Trial
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
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.
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.
;
Primary Purpose: Treatment
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