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 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:

MedlinePlus related topics: Cancer 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 ] [ 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:

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

No publications provided by International Atomic Energy Agency

Additional 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. 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
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 May 22, 2013

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