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

International Atomic Energy Agency

Status and phase: Completed; Phase 3

Conditions: Head and Neck Cancer

Treatments: Radiation: Accelerated Radiotherapy Fractionation

Study type: Interventional

Funder types: Other

Identifiers

NCT00120211

E33018

Details and patient eligibility

About

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

Full 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.

Enrollment: 855 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Head and Neck Cancer

Exclusion criteria

• Unable to give an informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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855 participants in 2 patient groups

Radiotherapy: 6 Fractions

Experimental group

Treatment:

Radiation: Accelerated Radiotherapy Fractionation

Radiation: Accelerated Radiotherapy Fractionation

Radiotherapy: 5 fractions

Active Comparator group

Treatment:

Radiation: Accelerated Radiotherapy Fractionation

Radiation: Accelerated Radiotherapy Fractionation