Long Term Results of the Canadian Breast IMRT Study (IMRT-FU)

March 1, 2013 updated by: Sunnybrook Health Sciences Centre

Long Term Outcomes of a Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy

Women diagnosed with an early stage cancer of the breast usually have the cancer removed by lumpectomy and then have radiation treatments to the entire breast. In 2008 the investigators published the result of a multicentre study showing that breast Intensity Modulated Radiation Therapy (IMRT) significantly reduces the occurrence of radiation burns. In this study the investigators will recall all patients at 8 years to assess if this technique also reduces permanent side effects including pain and cosmesis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In 2008 our group published the results of a multicentre, randomized, double-blinded study comparing standard radiotherapy to breast IMRT. The study showed a significant reduction moist desquamation using breast IMRT from 47.8% to 31.2% (p=0.002). There are two other Phase III trials showing improvement of long term cosmetic outcomes. Yet the use of breast IMRT remains not widely accepted. This trial aims at evaluating long term tolerance of breast IMRT compared to standard radiotherapy.

The investigators hypothesize that breast IMRT reduces the occurence of chronic breast pain (primary objective), improves cosmesis, reduces the occurence of delayed and permanent radiation induced skin side effects (telangiectasia, dryness, induration, edema, discolorations), improves quality of life. The investigators also hypothesize that there will not be differences in the local control rate or survival.

Study Type

Interventional

Enrollment (Anticipated)

358

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R6V5
        • Vancouver Island Cancer Centre
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • Sunnybrook Odette Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients treated in the Canadian Phase 3 randomised controlled trial breast IMRT trial

Exclusion Criteria:

  • Patients declining participating to this study
  • Patients unable to travel to the study site
  • Patients deceased

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard breast radiotherapy
The treatment is planned using 2D wedges optimisation on the central CT-planning slice.
Device: Adjuvant breast radiotherapy
Adjuvant radiotherapy delivering 50 Gy in 25 treatments, with an additional boost dose of 16 Gy at the discretion of the radiation oncologist.
Other Names:
  • Intensity Modulated Radiation Therapy
Experimental: Breast IMRT
The treatment is planned 3D IMRT optimisation using all CT-planning slices.
Device: Adjuvant breast radiotherapy
Adjuvant radiotherapy delivering 50 Gy in 25 treatments, with an additional boost dose of 16 Gy at the discretion of the radiation oncologist.
Other Names:
  • Intensity Modulated Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic breast pain using Visual Analog Scale
Time Frame: 8 years plus or minus one year
Quantitatively patients will be asked if they have spontaneous breast pain in the treated breast during the last 6 months, and will be asked to rate its intensity using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (extreme pain).
8 years plus or minus one year
Chronic breast pain using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0)
Time Frame: 8 years plus or minus one year
Quantitatively pain intensity will be evaluated using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0).
8 years plus or minus one year
Chronic breast pain using the prescription of pain killer
Time Frame: 8 years plus or minus one year
The use of pain killer will be recorded.
8 years plus or minus one year
Chronic breast pain using the McGill pain questionnaire
Time Frame: 8 years plus or minus one year
Qualitatively the pain will be evaluated and scored using the short form of the McGill pain questionnaire.
8 years plus or minus one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin and sub-cutaneous delayed side effects using the European Organization for Research and Treatment of Cancer (EORTC) scale
Time Frame: 8 years plus or minus one year
Skin and subcutaneous late radiation toxicity will be assessed by the clinical trial assistant using the European Organization for Research and Treatment of Cancer (EORTC) breast cancer rating system for the cosmesis assessment. This scale evaluates skin discoloration and oedema comparing between breasts as no, small, moderate or large differences.
8 years plus or minus one year
Cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS)
Time Frame: 8 years plus or minus one year
The patient's cosmesis self-report will be used as most reliable cosmetic endpoint and will use the Breast Cancer Treatment Outcome Scale (BCTOS).
8 years plus or minus one year
Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) general module questionnaire (C-30)
Time Frame: 8 years plus or minus one year
At time of initial treatment patient's quality of life was assessed at baseline, the last week of treatment, and 6 weeks after treatment using the European Organization for Research and Treatment of Cancer (EORTC) quality of life general module (C-30) self-assessment questionnaire. The same questionnaire will be administered to ensure consistency in the quality of life assessment and enable comparisons over time for individuals and cohorts.
8 years plus or minus one year
Skin and sub-cutaneous delayed telangiectasia
Time Frame: 8 years plus or minus one year
Telangiectasia will be classified into four categories of surface: none, less than 1cm2, 1 to 4 cm2 and over 4cm2.
8 years plus or minus one year
Skin and sub-cutaneous induration
Time Frame: 8 years plus or minus one year
Induration will be evaluated using the Late Radiation Morbidity Scoring Scheme scale that classifies fibrosis in four grades.
8 years plus or minus one year
Cosmesis using the European Organization for Research and Treatment of Cancer (EORTC) scale
Time Frame: 8 years plus or minus one year
Research assistant will use the four point scale European Organization for Research and Treatment of Cancer (EORTC) to evaluate cosmesis.
8 years plus or minus one year
Cosmesis using digital photographs
Time Frame: 8 years plus or minus one year
Digital photographs will be taken of the treated and untreated breasts and will be evaluated for cosmetic results by four blinded individuals using the EORTC criteria and the consensus score will be recorded.
8 years plus or minus one year
Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) breast module questionnaire (BR-23)
Time Frame: 8 years plus or minus one year
At time of initial treatment patient's quality of life was assessed at baseline, the last week of treatment, and 6 weeks after treatment using the European Organization for Research and Treatment of Cancer (EORTC) quality of life breast module (BR-23) self-assessment questionnaire. The same questionnaire will be administered to ensure consistency in the quality of life assessment and enable comparisons over time for individuals and cohorts.
8 years plus or minus one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

British Columbia Cancer Agency

Investigators

  • Principal Investigator: Jean-Philippe PIGNOL, MD, PhD, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Estimate)

March 4, 2013

Last Update Submitted That Met QC Criteria

March 1, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMRT-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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