Status:
COMPLETED
A Clinical Trial to Reduce Skin Burn Induced by Breast Radiotherapy Using Intensity Modulated Radiation Therapy (IMRT)
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
British Columbia Cancer Agency
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether the use of a 3D missing tissue compensation radiation technique during a standard adjuvant breast radiotherapy delivering a dose of 50Gy in 25 treatme...
Detailed Description
1. Description of the Problem: The majority of breast cancer patients are treated with breast-conserving surgery followed by radiotherapy, giving loco-regional control rates similar to mastectomy....
Eligibility Criteria
Inclusion
- A confirmed histological diagnosis of breast carcinoma or DCIS;
- Treated by breast conserving surgery;
- Adjuvant radiation to the breast only (less than 3 positive lymph nodes);
- Having a ECOG performance status of 0 or 1.
- Having signed an informed consent.
Exclusion
- Patients treated by mastectomy;
- Bilateral breast cancer;
- Having an unhealed surgical scar (skin not closed and/or infection);
- Having had prior radiation to the same breast;
- Having active connective tissue disorder;
- Patient being pregnant.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00187343
Start Date
September 1 2003
End Date
June 1 2005
Last Update
September 8 2008
Active Locations (2)
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1
BC Cancer Agency-Vancouver Island Centre
Victoria, British Columbia, Canada, V8R6V5
2
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5