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
18 Years
N/A
Both
Breast Cancer
Trial Information
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
- 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).
Inclusion Criteria:
- Patients must have newly diagnosed, clinical Stage I-III breast cancer with T1-T3
invasive tumors recently treated with mastectomy
- Patients must have had immediate reconstruction with a TE and ADM
- Participants must be candidates for postmastectomy radiation therapy (RT).
Postmastectomy RT routinely is indicated for patients with pathologically-staged T3N1
(or higher stage) tumors, T1-T2 tumors with 4 or more positive nodes, some T1-T2
tumors with 1-3 positive nodes, and, infrequently, for some N0 tumors
- Axillary nodes may be positive or negative
- Microscopically positive margins are permitted
- Systemic therapy as recommended by a medical oncologist, pre-or post-mastectomy, is
permitted
- Patients must agree to return for scheduled follow-up visits with their radiation
oncologist 6, 12, 18 and 24 months after RT (+/- 1 month)
- 18 years of age or older
Exclusion Criteria:
- Participants with T4 tumors
- Participants with recurrent breast cancer or a history of prior breast RT
- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements
- Pregnant women are excluded from this study
- Individuals with a history of a different malignancy are ineligible except for the
following circumstances. Individuals with a history of other malignancies are
eligible if they have been disease-free for at least 5 years and are deemed by the
investigator to be at low risk for recurrence of that malignancy. Individuals with
the following cancers are eligible if diagnosed and treated within the past 5 years:
cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
- HIV-positive individuals on combination antiretroviral therapy
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
The success rate of immediate reconstruction with a tissue expander and acellular dermal matrix followed by radiation therapy.
Outcome Description:
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.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Julia Wong, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
09-254
NCT ID:
NCT01664091
Start Date:
October 2009
Completion Date:
Related Keywords:
- Breast Cancer
- tissue expander
- acellular dermal matrix
- Breast Neoplasms
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
