Clinical trial NCT01803139: Long Term Results of the Canadian Breast IMRT Study
Official title: Long Term Outcomes of a Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast cancer radiotherapy IMRT
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: British Columbia Cancer Agency
First posted: 2013-03-04
Enrollment: 358
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chronic breast pain using Visual Analog Scale
timeFrame: 8 years plus or minus one year
measure: Chronic breast pain using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0)
timeFrame: 8 years plus or minus one year
measure: Chronic breast pain using the prescription of pain killer
timeFrame: 8 years plus or minus one year
measure: Chronic breast pain using the McGill pain questionnaire
timeFrame: 8 years plus or minus one year
Secondary outcomes:
measure: Skin and sub-cutaneous delayed side effects using the European Organization for Research and Treatment of Cancer (EORTC) scale
timeFrame: 8 years plus or minus one year
measure: Cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS)
timeFrame: 8 years plus or minus one year
measure: Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) general module questionnaire (C-30)
timeFrame: 8 years plus or minus one year
measure: Skin and sub-cutaneous delayed telangiectasia
timeFrame: 8 years plus or minus one year
measure: Skin and sub-cutaneous induration
timeFrame: 8 years plus or minus one year
measure: Cosmesis using the European Organization for Research and Treatment of Cancer (EORTC) scale
timeFrame: 8 years plus or minus one year
measure: Cosmesis using digital photographs
timeFrame: 8 years plus or minus one year
measure: Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) breast module questionnaire (BR-23)
timeFrame: 8 years plus or minus one year
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Vancouver Island Cancer Centre
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Jean-Philippe Pignol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pignol JP, Olivotto I, Rakovitch E, Gardner S, Sixel K, Beckham W, Vu TT, Truong P, Ackerman I, Paszat L. A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol. 2008 May 1;26(13):2085-92. doi: 10.1200/JCO.2007.15.2488. Epub 2008 Feb 19.