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Study Summary
No.
2004-0955:
.......
Breast
......
Steven J. Kronowitz
......
Reconstructive and Plastic Sur
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Study Summary Title
Study Summary
Number:
2004-0955
Study Title:
Delayed-Immediate Breast Reconstruction
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Physician
New Patient Referral
Name:
Steven J. Kronowitz
Patients Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:
Reconstructive and Plastic Sur
Referring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:
713-792-7300
Contact us about clinical trials
.
General Information
Disease Group:
Breast
Supported By:
N/A
Phase of Study:
N/A
Return
Visit:
Standard preoperative and postoperative visits for patients undergoing
mastectomy and reconstruction. In patients that require XRT, additional
follow-up visits will be required for re-expansion of the expander or implant
after the completion of XRT.
Treatment
Agents:
None
Home Care:
None
Treatment Loc:
Only at MDACC
Estimated
Length of Stay
in Houston:
Mastectomy and Delayed-Immediate Reconstruction (Stage 1): 2-3 days
No XRT: Delayed-Immediate Breast Reconstruction (Stage 2): 5 days, or
XRT: "Skin-Preserving" Delayed Breast Reconstruction: 5 days
Description/
Intervention:
The goal of this clinical research study is to evaluate a new two-stage
approach (delayed-immediate reconstruction) to breast reconstruction in women
who may require post-mastectomy radiation therapy. Researchers will compare
the cosmetic outcomes and any complications that occur in women who receive
delayed-immediate reconstruction to those who receive the standard approaches
(either immediate reconstruction or delayed breast reconstruction).
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Study Objectives / Outcomes
Determine the safety and efficacy of delayed-immediate breast reconstruction.
Compare the aesthetic outcomes and complications rates with those reported for immediate and delayed breast reconstruction at The University of Texas M. D. Anderson Cancer Center.
Determine the histologic, immunologic, histochemical and molecular changes associated with the radiated and re-expanded breast skin that is preserved in patients that require postmastectomy radiation.
Evaluate the impact on radiation delivery in regards to the design of the radiation fields and the occurrence of complications with a deflated tissue expander with an integrated saline-filling port or a postoperatively adjustable implant with a remote saline-filling port on the chest wall.
To determine any subsequent alterations to the structural integrity of the breast prosthesis with evaluation of various breast prosthetic prototype designs.
To determine if a remote saline-filling port location avoids radiation scatter by placement of the metallic filling port away from the radiation field and if scatter from the integrated ports within the tissue expanders has any clinical significance.
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Study Status Information
Study Activation / Registration Date:
04/14/2005
IRB Review and Approval Date:
02/16/2005
Study Type:
Not Applicable
Recruitment Status:
Open
Projected Accrual:
N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you.
Please Contact the
Referral Office
for more information.
Inclusion Criteria:
1) Patients with clinical stage I or stage II breast cancer who may require postmastectomy XRT.
2) Patients will be required to receive postmastectomy XRT as well as breast reconstructive procedures, including subsequent deflation and re-inflation of the prosthesis after XRT at MDACC.
3) Patients must sign the consent form and must be able to withstand two (2) anesthetic procedures.
4) Patients with stage I breast cancer who will be eligible for delayed-immediate breast reconstruction will have extensive microcalcifications within the affected by mammography that make it difficult to determine preoperatively the extent of invasive disease.
Exclusion Criteria:
1) Patients with stage III or stage IV breast cancer who are known preoperatively to require postmastectomy XRT.
2) Patients with stage I breast cancer who are unlikely to require postmastectomy XRT.
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Links
Registration Number:
NCT00473122
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
.
Results
Return to Clinical Trials at M.D. Anderson Cancer Center
