Radiation Therapy in Treating Patients With Head and Neck Cancer

Phase 3

Completed

• Conditions: Head and Neck Cancer; Non-melanomatous Skin Cancer

• Registration Number: NCT00021125
• Lead Sponsor: Medical Research Council

Brief 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.

Study Timeline

• Study Start: 2000-07
• Study First Submitted: 2001-07-11
• Status Verified: 2002-12
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Completion: 2007-06
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to local recurrence

Secondary Outcome Measures

Name	Time	Method
Length of survival
Morbidity and toxicity
Quality of life as assessed by EORTC Quality of life Questionnaire for Head and Neck Cancer

Trial Locations

Locations (1)

Mount Vernon Cancer Centre at Mount Vernon Hospital; 🇬🇧 Northwood, England, United Kingdom