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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Accelerated Radiotherapy Fractionation
Accelerated Radiotherapy Fractionation
Sponsored by
International Atomic Energy Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Head and Neck Cancer Exclusion Criteria: Unable to give an informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Radiotherapy: 6 Fractions

    Radiotherapy: 5 fractions

    Arm Description

    Outcomes

    Primary Outcome Measures

    Three Years Loco-regional Control

    Secondary Outcome Measures

    Disease-specific Survival
    Overall Survival
    Acute Adverse Effects
    Late Adverse Effects

    Full Information

    First Posted
    July 8, 2005
    Last Updated
    October 12, 2011
    Sponsor
    International Atomic Energy Agency
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00120211
    Brief Title
    Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer
    Official Title
    Phase III Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1998 (undefined)
    Primary Completion Date
    May 2006 (Actual)
    Study Completion Date
    May 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    International Atomic Energy Agency

    4. Oversight

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    855 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Radiotherapy: 6 Fractions
    Arm Type
    Experimental
    Arm Title
    Radiotherapy: 5 fractions
    Arm Type
    Active Comparator
    Intervention Type
    Radiation
    Intervention Name(s)
    Accelerated Radiotherapy Fractionation
    Intervention Description
    Radiation Therapy 6 fractions per week
    Intervention Type
    Radiation
    Intervention Name(s)
    Accelerated Radiotherapy Fractionation
    Intervention Description
    Radiotherapy 5 fractions per week
    Primary Outcome Measure Information:
    Title
    Three Years Loco-regional Control
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Disease-specific Survival
    Time Frame
    8 years
    Title
    Overall Survival
    Time Frame
    8 years
    Title
    Acute Adverse Effects
    Title
    Late Adverse Effects
    Time Frame
    8 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Head and Neck Cancer Exclusion Criteria: Unable to give an informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eduardo Rosenblatt, M.D.
    Organizational Affiliation
    International Atomic Energy Agency (IAEA)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20382075
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://www.iaea.org
    Description
    International Atomic Energy Agency, Research Contracts Administration

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

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