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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Atomic Energy Agency
ClinicalTrials.gov Identifier:
NCT00120211
First received: July 8, 2005
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Head and Neck Cancer
Radiation: Accelerated Radiotherapy Fractionation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by International Atomic Energy Agency:

Primary Outcome Measures:
  • Three Years Loco-regional Control [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-specific Survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Acute Adverse Effects [ Designated as safety issue: Yes ]
  • Late Adverse Effects [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]

Enrollment: 855
Study Start Date: September 1998
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Head and Neck Cancer

Exclusion Criteria:

  • Unable to give an informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120211

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

Additional Information:
No publications provided by International Atomic Energy Agency

Additional 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
Study First Received: July 8, 2005
Last Updated: October 12, 2011
Health Authority: United Nations: International Atomic Energy Agency

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

ClinicalTrials.gov processed this record on April 23, 2014