Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer
Phase 3
Completed
- Conditions
- Head and Neck Cancer
- Interventions
- Radiation: Accelerated Radiotherapy Fractionation
- Registration Number
- NCT00120211
- Lead Sponsor
- International Atomic Energy Agency
- Brief Summary
This trial compares the use of 6 fractions versus the standard 5 fractions of radiotherapy used in the treatment of head and neck cancer.
- Detailed Description
The purpose of this trial is to study the clinical effects of increasing the weekly fraction number for locally advanced head and neck cancers by a multi-institutional prospective randomised trial. The primary endpoint is to clarify whether a six fraction per week protocol has a greater effect on the survival, as compared to the conventional five fraction per week protocol.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 855
Inclusion Criteria
- Head and Neck Cancer
Exclusion Criteria
- Unable to give an informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiotherapy: 6 Fractions Accelerated Radiotherapy Fractionation - Radiotherapy: 5 fractions Accelerated Radiotherapy Fractionation -
- Primary Outcome Measures
Name Time Method Three Years Loco-regional Control 3 years
- Secondary Outcome Measures
Name Time Method Disease-specific Survival 8 years Overall Survival 8 years Acute Adverse Effects Late Adverse Effects 8 years