Cosmetic Result/Toxicity in Post-Mastectomy Immediate Reconstruction Expander+RT
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|ClinicalTrials.gov Identifier: NCT01664091|
Recruitment Status : Active, not recruiting
First Posted : August 14, 2012
Last Update Posted : June 7, 2017
|Condition or disease||Intervention/treatment|
|Breast Cancer||Radiation: Radiation Therapy|
- ADMs have been used in combination with a tissue expander and radiotherapy but have not been studied formally in terms of their ability to avoid complications sometimes seen with other methods of reconstruction and improve the delivery of the radiation. The only difference between being on the study and not being on the study is that the research team will analyze the records of those who participate to see how easy it was to give the radiation, how good the cosmetic outcome of the reconstruction is and what, if any, complications occured.
- A minimum of 6 weeks between the surgery and the start of radiation therapy is required to allow for adequate healing. Often this interval will be longer, as many patients will receive chemotherapy in the interim. There is no maximum time from surgery to radiation.
- Around the time of radiation planning, the radiation oncologist and plastic surgeon will agree upon how much deflation of the tissue expander will be required to permit simulation of the radiation therapy.
- Radiation therapy to the chest wall (with or without adjacent lymph nodes) will be given once daily Monday through Friday over 5-7 weeks.
- After the completion of the radiation therapy, the tissue expander will be re-expanded and eventually replaced by the permanent implant or flap reconstruction at the discretion of the plastic surgeon.
- Participants will be expected to return to the Radiation Oncology Clinic for follow-up visits 6, 12, 18 and 24 months after the end of the radiation therapy. Evaluation of cosmetic results and complications will be done at these visits using a recognized scoring system and photographs taken at each time point and scored for specific items (necrosis, telangiectasia, etc).
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|Official Title:||An Evaluation of Cosmetic Results and Toxicity in the Use of Post-Mastectomy Immediate Reconstruction With a Tissue Expander and Acellular Dermal Matrix Followed by Radiation Therapy|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
Radiation: Radiation Therapy
- The success rate of immediate reconstruction with a tissue expander and acellular dermal matrix followed by radiation therapy. [ Time Frame: 2 years ]Outcomes will be measured by the ability to complete RT and placement of the permanent implant and/or flap reconstruction, the absence of significant complications, and an acceptable cosmetic result. Major complications are defined as: infection requiring hospitalization, major revisions, early capsular contracture, or pain requiring implant removal. An acceptable cosmetic result (excellent or good, on a scale of excellent-good-fair-poor) is defined as: a stable reconstruction with good symmetry and contour relative to the contralateral breast. The rate of complications and the cosmetic outcome after RT will be recorded by the radiation oncologist at predetermined times (6, 12, 18 and 24 months) after completion of RT and by the plastic surgeon at follow-up visits using photographs.
- To evaluate the volumes of lung and heart (if left-sided) included in the radiation fields. [ Time Frame: 2 years ]Lung volumes will be assessed as a percentage of the ipsilateral lung irradiated and via dose-volume histograms, and heart volumes will be measured in cubic centimeters (cc) and with a dose-volume histogram.
- To assess the extent and location of contracture. [ Time Frame: 2 years ]Outcome will be measured by means of strict photographic analysis using five views (frontal, right and left lateral, and right and left quarter views) and independent assessment of the results by a plastic surgeon or radiation oncologist who has not treated the patient.The modified Baker classification will be used to score the extent of contracture seen in the photographs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664091
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Julia Wong, MD||Dana-Farber Cancer Institute|