Status:
COMPLETED
The Prone Breast Radiation Therapy Trial
Lead Sponsor:
Toronto Sunnybrook Regional Cancer Centre
Collaborating Sponsors:
Canadian Breast Cancer Foundation
Conditions:
Ductal Carcinoma In Situ
Invasive Breast Cancer
Eligibility:
FEMALE
Phase:
NA
Brief Summary
Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk ...
Detailed Description
The risk of moist desquamation in large breasted women remains unacceptably high and reactions tends to be severe and produce significant permanent and delayed side effects. Evidence suggests that the...
Eligibility Criteria
Inclusion
- confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ (DCIS);
- treated with BCT;
- no indication for treatment of regional LN;
- Women with a bra size of 40 inches or greater, or a pre-surgery cup size of D or greater
Exclusion
- Regional Lymph Node XRT indicated;
- Bilateral breast cancer;
- unhealed wound (skin not closed and/or infection);
- previous XRT to the same breast;
- unable to lie prone;
- presence of active connective tissue disease;
- pregnancy;
- unacceptable heart exposure (as measured by \> 10% of the heart receiving 50% of the prescribed dose, i.e. V25Gy \> 10%);
- adequate coverage of postoperative tumour bed not technically possible
Key Trial Info
Start Date :
May 4 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT01815476
Start Date
May 4 2013
End Date
June 1 2019
Last Update
September 11 2019
Active Locations (2)
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1
British Columbia Cancer Agency - Vancouver Island centre
Victoria, British Columbia, Canada, V8R6V5
2
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5