Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
358 participants
INTERVENTIONAL
2013-04-30
2014-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Standard breast radiotherapy
The treatment is planned using 2D wedges optimisation on the central CT-planning slice.
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.
Breast IMRT
The treatment is planned 3D IMRT optimisation using all CT-planning slices.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients unable to travel to the study site
* Patients deceased
20 Years
FEMALE
No
Sponsors
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British Columbia Cancer Agency
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Jean-Philippe Pignol, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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Vancouver Island Cancer Centre
Victoria, British Columbia, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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IMRT-02
Identifier Type: -
Identifier Source: org_study_id
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