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

NCT ID: NCT00120211

Last Updated: 2011-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

855 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2006-05-31

Brief Summary

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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

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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.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiotherapy: 6 Fractions

Group Type EXPERIMENTAL

Accelerated Radiotherapy Fractionation

Intervention Type RADIATION

Radiation Therapy 6 fractions per week

Radiotherapy: 5 fractions

Group Type ACTIVE_COMPARATOR

Accelerated Radiotherapy Fractionation

Intervention Type RADIATION

Radiotherapy 5 fractions per week

Interventions

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Accelerated Radiotherapy Fractionation

Radiation Therapy 6 fractions per week

Intervention Type RADIATION

Accelerated Radiotherapy Fractionation

Radiotherapy 5 fractions per week

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Head and Neck Cancer

Exclusion Criteria

* Unable to give an informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Atomic Energy Agency

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eduardo Rosenblatt, M.D.

Role: STUDY_DIRECTOR

International Atomic Energy Agency (IAEA)

References

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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.

Reference Type DERIVED
PMID: 20382075 (View on PubMed)

Related Links

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http://www.iaea.org

International Atomic Energy Agency, Research Contracts Administration

Other Identifiers

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E33018

Identifier Type: -

Identifier Source: org_study_id