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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00120211
Recruitment Status : Completed
First Posted : July 15, 2005
Last Update Posted : October 13, 2011
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: Accelerated Radiotherapy Fractionation Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 855 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer
Study Start Date : September 1998
Primary Completion Date : May 2006
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Three Years Loco-regional Control [ Time Frame: 3 years ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Head and Neck Cancer

Exclusion Criteria:

  • Unable to give an informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120211

Sponsors and Collaborators
International Atomic Energy Agency
Study Director: Eduardo Rosenblatt, M.D. International Atomic Energy Agency (IAEA)
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Atomic Energy Agency
ClinicalTrials.gov Identifier: NCT00120211     History of Changes
Other Study ID Numbers: E33018
First Posted: July 15, 2005    Key Record Dates
Last Update Posted: October 13, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site