Cosmetic Result/Toxicity in Post-Mastectomy Immediate Reconstruction Expander+RT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01664091
Recruitment Status : Active, not recruiting
First Posted : August 14, 2012
Last Update Posted : June 7, 2017
Brigham and Women's Hospital
Information provided by (Responsible Party):
Julia S. Wong, MD, Dana-Farber Cancer Institute

Brief Summary:
This research study is being done to carefully evaluate the effect of giving radiation therapy after temporary breast reconstruction. The investigators want to see if this type of reconstruction combined with radiation will look better (once the final reconstruction has been completed) and will reduce the risk that the participant will develop complications that sometimes occur with other kinds of reconstruction procedures. The investigators also want to know if it is easier to give the radiation with this type of reconstruction than with other kinds of reconstruction procedures. The reconstruction procedure involves the temporary use of a tissue expander and an acellular dermal matrix (ADM).

Condition or disease Intervention/treatment
Breast Cancer Radiation: Radiation Therapy

Detailed Description:
  • 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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Radiation: Radiation Therapy
    Given Monday through Friday over 5-7 weeks

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be invited to take part in this clinical trial because they have breast cancer that was recently treated with mastectomy and the participant and their doctors have decided that additional treatment with radiation therapy is the best course.

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

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Julia Wong, MD Dana-Farber Cancer Institute

Responsible Party: Julia S. Wong, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT01664091     History of Changes
Other Study ID Numbers: 09-254
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017

Keywords provided by Julia S. Wong, MD, Dana-Farber Cancer Institute:
tissue expander
acellular dermal matrix