Long Term Results of the Canadian Breast IMRT Study (IMRT-FU)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Adjuvant breast radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer radiotherapy IMRT
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
Sites / Locations
- Vancouver Island Cancer Centre
- Sunnybrook Odette Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard breast radiotherapy
Breast IMRT
Arm Description
The treatment is planned using 2D wedges optimisation on the central CT-planning slice.
The treatment is planned 3D IMRT optimisation using all CT-planning slices.
Outcomes
Primary Outcome Measures
Chronic breast pain using Visual Analog Scale
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)
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
The use of pain killer will be recorded.
Chronic breast pain using the McGill pain questionnaire
Qualitatively the pain will be evaluated and scored using the short form of the McGill pain questionnaire.
Secondary Outcome Measures
Skin and sub-cutaneous delayed side effects using the European Organization for Research and Treatment of Cancer (EORTC) scale
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)
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)
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
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
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
Research assistant will use the four point scale European Organization for Research and Treatment of Cancer (EORTC) to evaluate cosmesis.
Cosmesis using digital photographs
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)
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.
Full Information
NCT ID
NCT01803139
First Posted
March 1, 2012
Last Updated
March 1, 2013
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
British Columbia Cancer Agency
1. Study Identification
Unique Protocol Identification Number
NCT01803139
Brief Title
Long Term Results of the Canadian Breast IMRT Study
Acronym
IMRT-FU
Official Title
Long Term Outcomes of a Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
British Columbia Cancer Agency
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer radiotherapy IMRT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
358 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard breast radiotherapy
Arm Type
Active Comparator
Arm Description
The treatment is planned using 2D wedges optimisation on the central CT-planning slice.
Arm Title
Breast IMRT
Arm Type
Experimental
Arm Description
The treatment is planned 3D IMRT optimisation using all CT-planning slices.
Intervention Type
Device
Intervention Name(s)
Adjuvant breast radiotherapy
Other Intervention Name(s)
Intensity Modulated Radiation Therapy
Intervention Description
Adjuvant radiotherapy delivering 50 Gy in 25 treatments, with an additional boost dose of 16 Gy at the discretion of the radiation oncologist.
Primary Outcome Measure Information:
Title
Chronic breast pain using Visual Analog Scale
Description
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).
Time Frame
8 years plus or minus one year
Title
Chronic breast pain using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0)
Description
Quantitatively pain intensity will be evaluated using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0).
Time Frame
8 years plus or minus one year
Title
Chronic breast pain using the prescription of pain killer
Description
The use of pain killer will be recorded.
Time Frame
8 years plus or minus one year
Title
Chronic breast pain using the McGill pain questionnaire
Description
Qualitatively the pain will be evaluated and scored using the short form of the McGill pain questionnaire.
Time Frame
8 years plus or minus one year
Secondary Outcome Measure Information:
Title
Skin and sub-cutaneous delayed side effects using the European Organization for Research and Treatment of Cancer (EORTC) scale
Description
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.
Time Frame
8 years plus or minus one year
Title
Cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS)
Description
The patient's cosmesis self-report will be used as most reliable cosmetic endpoint and will use the Breast Cancer Treatment Outcome Scale (BCTOS).
Time Frame
8 years plus or minus one year
Title
Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) general module questionnaire (C-30)
Description
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.
Time Frame
8 years plus or minus one year
Title
Skin and sub-cutaneous delayed telangiectasia
Description
Telangiectasia will be classified into four categories of surface: none, less than 1cm2, 1 to 4 cm2 and over 4cm2.
Time Frame
8 years plus or minus one year
Title
Skin and sub-cutaneous induration
Description
Induration will be evaluated using the Late Radiation Morbidity Scoring Scheme scale that classifies fibrosis in four grades.
Time Frame
8 years plus or minus one year
Title
Cosmesis using the European Organization for Research and Treatment of Cancer (EORTC) scale
Description
Research assistant will use the four point scale European Organization for Research and Treatment of Cancer (EORTC) to evaluate cosmesis.
Time Frame
8 years plus or minus one year
Title
Cosmesis using digital photographs
Description
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.
Time Frame
8 years plus or minus one year
Title
Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) breast module questionnaire (BR-23)
Description
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.
Time Frame
8 years plus or minus one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Philippe Pignol, MD, PhD
Phone
416 480 4998
Email
jean-philippe.pignol@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline Truong, MD, MSc
Email
ptruong@bccancer.bc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Pignol, MD, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver Island Cancer Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R6V5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Truong, MD, MSc
Email
ptruong@bccancer.bc.ca
First Name & Middle Initial & Last Name & Degree
Michael Miller
Email
MMiller2@bccancer.bc.ca
First Name & Middle Initial & Last Name & Degree
Pauline Truong, MD, MSc
First Name & Middle Initial & Last Name & Degree
Ivo A Olivotto, MD
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Pignol, MD, PhD
Phone
416 480 4998
Email
jean-philippe.pignol@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Eileen Rakovitch, MD, MSc
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Pignol, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
18285602
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.
Results Reference
result
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Long Term Results of the Canadian Breast IMRT Study
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