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

October 12, 2011 updated by: International Atomic Energy Agency

Phase III 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

855

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Head and Neck Cancer

Exclusion Criteria:

  • Unable to give an informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiotherapy: 6 Fractions
Radiation: Accelerated Radiotherapy Fractionation
Radiation Therapy 6 fractions per week
Radiation: Accelerated Radiotherapy Fractionation
Radiotherapy 5 fractions per week
Active Comparator: Radiotherapy: 5 fractions
Radiation: Accelerated Radiotherapy Fractionation
Radiation Therapy 6 fractions per week
Radiation: Accelerated Radiotherapy Fractionation
Radiotherapy 5 fractions per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Three Years Loco-regional Control
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 8 years
8 years
Disease-specific Survival
Time Frame: 8 years
8 years
Acute Adverse Effects
Late Adverse Effects
Time Frame: 8 years
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Atomic Energy Agency

Investigators

  • Study Director: Eduardo Rosenblatt, M.D., International Atomic Energy Agency (IAEA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1998

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

July 8, 2005

First Submitted That Met QC Criteria

July 8, 2005

First Posted (Estimate)

July 15, 2005

Study Record Updates

Last Update Posted (Estimate)

October 13, 2011

Last Update Submitted That Met QC Criteria

October 12, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E33018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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