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NCT00120211 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00120211
Other study ID # E33018
Secondary ID
Status Completed
Phase Phase 3
First received July 8, 2005
Last updated October 12, 2011
Start date September 1998
Est. completion date May 2006

Study information
Verified date October 2011
Source International Atomic Energy Agency
Contact n/a
Is FDA regulated No
Health authority United Nations: International Atomic Energy Agency
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 855
Est. completion date May 2006
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Head and Neck Cancer

Exclusion Criteria:

- Unable to give an informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Radiation:
• Accelerated Radiotherapy Fractionation
Radiation Therapy 6 fractions per week
• Accelerated Radiotherapy Fractionation
Radiotherapy 5 fractions per week

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
International Atomic Energy Agency

Outcome
Type Measure Description Time frame Safety issue
Primary Three Years Loco-regional Control 3 years No
Secondary Disease-specific Survival 8 years No
Secondary Overall Survival 8 years No
Secondary Acute Adverse Effects Yes
Secondary Late Adverse Effects 8 years Yes
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