Long Term Results of the Canadian Breast IMRT Study
IMRT-FU
Long Term Outcomes of a Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
1 other identifier
interventional
358
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 breast-cancer
Started Apr 2013
Shorter than P25 for phase_3 breast-cancer
2 active sites
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
First Submitted
Initial submission to the registry
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 4, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 4, 2013
March 1, 2013
1.2 years
March 1, 2012
March 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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).
8 years plus or minus one year
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).
8 years plus or minus one year
Chronic breast pain using the prescription of pain killer
The use of pain killer will be recorded.
8 years plus or minus one year
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.
8 years plus or minus one year
Secondary Outcomes (8)
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
Cosmesis using 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)
8 years plus or minus one year
Skin and sub-cutaneous delayed telangiectasia
8 years plus or minus one year
Skin and sub-cutaneous induration
8 years plus or minus one year
- +3 more secondary outcomes
Study Arms (2)
Standard breast radiotherapy
ACTIVE COMPARATORThe treatment is planned using 2D wedges optimisation on the central CT-planning slice.
Breast IMRT
EXPERIMENTALThe treatment is planned 3D IMRT optimisation using all CT-planning slices.
Interventions
Adjuvant radiotherapy delivering 50 Gy in 25 treatments, with an additional boost dose of 16 Gy at the discretion of the radiation oncologist.
Eligibility Criteria
You may qualify if:
- Patients treated in the Canadian Phase 3 randomised controlled trial breast IMRT trial
You may not qualify if:
- Patients declining participating to this study
- Patients unable to travel to the study site
- Patients deceased
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- British Columbia Cancer Agencycollaborator
Study Sites (2)
Vancouver Island Cancer Centre
Victoria, British Columbia, V8R6V5, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N3M5, Canada
Related Publications (1)
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.
PMID: 18285602RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Philippe Pignol, MD, PhD
Sunnybrook Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2012
First Posted
March 4, 2013
Study Start
April 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
March 4, 2013
Record last verified: 2013-03