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 Therapy 6 fractions per week
Radiotherapy 5 fractions per week
|
|
Active Comparator: Radiotherapy: 5 fractions
|
Radiation Therapy 6 fractions per week
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.
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.
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.