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Completed

NCT Number: NCT00120211

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

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

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Head and Neck Cancer

Exclusion criteria

  • Unable to give an informed consent

Treatment and study plan

Accelerated Radiotherapy Fractionation

Radiation

Radiation Therapy 6 fractions per week

Primary outcomes

  1. Three Years Loco-regional Control

    Time frame: 3 years

Secondary outcomes

  1. Disease-specific Survival

    Time frame: 8 years

  2. Overall Survival

    Time frame: 8 years

  3. Acute Adverse Effects

  4. Late Adverse Effects

    Time frame: 8 years

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Sponsors and collaborators

Lead sponsor

International Atomic Energy Agency

Other Gov

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2006
Study completion
2006
First posted
Jul 15, 2005
Registry last updated
Oct 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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