NCT00021125

Radiation Therapy in Treating Patients With Head and Neck Cancer

A Randomized Controlled Trial Of CHARTWEL (a Continuous Hyperfractionated Accelerated Radiotherapy Schedule) Versus Conventional Radiotherapy In Post-Operative Head And Neck Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Cancer
• Non-melanomatous Skin Cancer

Interventions

Type	Name	Description
PROCEDURE	adjuvant therapy
RADIATION	radiation therapy

Timeline

• Start date: 2000-07-01
• Completion: 2007-06-01
• First posted: 2003-01-27
• Last updated: 2013-06-26

Locations

1 site across 1 country: United Kingdom