Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 8, 2005
October 12, 2011
September 1998
May 2006   (final data collection date for primary outcome measure)
Three Years Loco-regional Control [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00120211 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer
Phase III Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer

This trial compares the use of 6 fractions versus the standard 5 fractions of radiotherapy used in the treatment of head and neck cancer.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Radiation: Accelerated Radiotherapy Fractionation
    Radiation Therapy 6 fractions per week
  • Radiation: Accelerated Radiotherapy Fractionation
    Radiotherapy 5 fractions per week
  • Experimental: Radiotherapy: 6 Fractions
    Intervention: Radiation: Accelerated Radiotherapy Fractionation
  • Active Comparator: Radiotherapy: 5 fractions
    Intervention: Radiation: Accelerated Radiotherapy Fractionation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
855
May 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Head and Neck Cancer

Exclusion Criteria:

  • Unable to give an informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00120211
E33018
Not Provided
International Atomic Energy Agency
International Atomic Energy Agency
Not Provided
Study Director: Eduardo Rosenblatt, M.D. International Atomic Energy Agency (IAEA)
International Atomic Energy Agency
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP