Status:
COMPLETED
Delayed-Delayed Breast Reconstruction
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of this clinical research study is to learn if delayed-delayed breast reconstruction in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and result in fewer ...
Detailed Description
Study Visits and Surgeries: You will be hospitalized 2-4 times for 1-5 days depending on your condition. If you agree to take part in this study, you will be scheduled for a skin-sparing mastectomy. ...
Eligibility Criteria
Inclusion
- Patients with invasive breast carcinoma that are scheduled for a mastectomy with planned postmastectomy XRT. This includes, but is not limited to, clinical stage II, III, and IV.
- Patient must desire breast reconstruction.
- Patients must sign the informed consent form and must be deemed by operative surgeon not to have medical contraindications for delayed-delayed approach.
- Patients must be 18 years of age or older.
Exclusion
- Patients in whom it is not known preoperatively to need postmastectomy radiation therapy.
- Patients with inflammatory breast cancer.
- Patients in whom the breast skin can not be spared because of involvement with breast cancer.
- Any patient deemed by the radiation oncologist during preoperative consultation to be an inappropriate patient for this protocol.
- Patients that can not commit to receiving postmastectomy radiation treatment in addition to breast reconstructive procedures at MD Anderson Cancer Center or satellite affiliates.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01256528
Start Date
December 1 2010
End Date
September 1 2015
Last Update
July 15 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030