NCT00120211

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
855

participants targeted

Target at P75+ for phase_3 head-and-neck-cancer

Timeline
Completed

Started Sep 1998

Typical duration for phase_3 head-and-neck-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

October 13, 2011

Status Verified

October 1, 2011

Enrollment Period

7.7 years

First QC Date

July 8, 2005

Last Update Submit

October 12, 2011

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Three Years Loco-regional Control

    3 years

Secondary Outcomes (4)

  • Disease-specific Survival

    8 years

  • Overall Survival

    8 years

  • Acute Adverse Effects

  • Late Adverse Effects

    8 years

Study Arms (2)

Radiotherapy: 6 Fractions

EXPERIMENTAL
Radiation: Accelerated Radiotherapy Fractionation

Radiotherapy: 5 fractions

ACTIVE COMPARATOR
Radiation: Accelerated Radiotherapy Fractionation

Interventions

Accelerated Radiotherapy FractionationRADIATION

Radiation Therapy 6 fractions per week

Radiotherapy: 6 Fractions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Head and Neck Cancer

You may not qualify if:

  • Unable to give an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20382075DERIVED

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Eduardo Rosenblatt, M.D.

    International Atomic Energy Agency (IAEA)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2005

First Posted

July 15, 2005

Study Start

September 1, 1998

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

October 13, 2011

Record last verified: 2011-10