Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer

Phase 3CompletedNCT00120211

International Atomic Energy Agency855 enrolled

Overview

This trial compares the use of 6 fractions versus the standard 5 fractions of radiotherapy used in the treatment of head and neck cancer.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

855

Conditions

Head and Neck Cancer

Interventions

Accelerated Radiotherapy FractionationRADIATION

Radiation Therapy 6 fractions per week

Accelerated Radiotherapy FractionationRADIATION

Radiotherapy 5 fractions per week

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Head and Neck Cancer Exclusion Criteria: * Unable to give an informed consent

Outcomes

Primary Outcomes

Three Years Loco-regional Control

Time frame: 3 years

Secondary Outcomes

Disease-specific Survival

Time frame: 8 years

Overall Survival

Time frame: 8 years

Acute Adverse Effects

Late Adverse Effects

Time frame: 8 years

Data from ClinicalTrials.gov

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