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

History of Changes

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 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:

MedlinePlus related topics: Head and Neck Cancer

U.S. FDA Resources

Further study details as provided by International Atomic Energy Agency:

Primary Outcome Measures:

Three Years Loco-regional Control [ Time Frame: 3 years ]

Secondary Outcome Measures:

Disease-specific Survival [ Time Frame: 8 years ]
Overall Survival [ Time Frame: 8 years ]
Acute Adverse Effects
Late Adverse Effects [ Time Frame: 8 years ]


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 (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Head and Neck Cancer

Exclusion Criteria:

Unable to give an informed consent

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

International Atomic Energy Agency, Research Contracts Administration This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Overgaard J, Mohanti BK, Begum N, Ali R, Agarwal JP, Kuddu M, Bhasker S, Tatsuzaki H, Grau C. Five versus six fractions of radiotherapy per week for squamous-cell carcinoma of the head and neck (IAEA-ACC study): a randomised, multicentre trial. Lancet Oncol. 2010 Jun;11(6):553-60. doi: 10.1016/S1470-2045(10)70072-3. Epub 2010 Apr 8.


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

Additional relevant MeSH terms:


Head and Neck Neoplasms Neoplasms by Site Neoplasms

ClinicalTrials.gov processed this record on June 27, 2017

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