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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00120211

Enrollment

855

Registered

2005-07-15

Start date

1998-09-30

Completion date

2006-05-31

Last updated

2011-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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.

Interventions

RADIATIONAccelerated Radiotherapy Fractionation

Radiation Therapy 6 fractions per week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Head and Neck Cancer

Exclusion criteria

* Unable to give an informed consent

Design outcomes

Primary

Measure	Time frame
Three Years Loco-regional Control	3 years

Secondary

Measure	Time frame
Disease-specific Survival	8 years
Overall Survival	8 years
Acute Adverse Effects	—
Late Adverse Effects	8 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026