Long Term Results of the Canadian Breast IMRT Study

Phase 3

• Conditions: Breast Cancer
• Interventions: Device: Adjuvant breast radiotherapy

• Registration Number: NCT01803139
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

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 Timeline

• Study First Submitted: 2012-03-01
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-01
• Last Update Submitted: 2013-03-01
• Study First Posted: 2013-03-04
• Last Update Posted: 2013-03-04
• Study Start: 2013-04
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 358

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard breast radiotherapy	Adjuvant breast radiotherapy	The treatment is planned using 2D wedges optimisation on the central CT-planning slice.
Breast IMRT	Adjuvant breast radiotherapy	The treatment is planned 3D IMRT optimisation using all CT-planning slices.

Primary Outcome Measures

Name	Time	Method
Chronic breast pain using Visual Analog Scale	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).
Chronic breast pain using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0)	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).
Chronic breast pain using the prescription of pain killer	8 years plus or minus one year	The use of pain killer will be recorded.
Chronic breast pain using the McGill pain questionnaire	8 years plus or minus one year	Qualitatively the pain will be evaluated and scored using the short form of the McGill pain questionnaire.

Secondary Outcome Measures

Name	Time	Method
Skin and sub-cutaneous delayed side effects using the European Organization for Research and Treatment of Cancer (EORTC) scale	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.
Cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS)	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).
Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) general module questionnaire (C-30)	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.
Skin and sub-cutaneous delayed telangiectasia	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.
Skin and sub-cutaneous induration	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.
Cosmesis using the European Organization for Research and Treatment of Cancer (EORTC) scale	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.
Cosmesis using digital photographs	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.
Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) breast module questionnaire (BR-23)	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.

Trial Locations

Locations (2)

Sunnybrook Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Vancouver Island Cancer Centre; 🇨🇦 Victoria, British Columbia, Canada