CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
post-mastectomy radiation therapy (PMRT) +2 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01664091
NCT01664091N/ACompleted

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

Dana-Farber Cancer Institute·interventional·Posted Aug 14, 2012·Updated Aug 26, 2019

In Brief

A clinical study evaluating post-mastectomy radiation therapy (PMRT), tissue expander (TE), and 1 other intervention for Breast Cancer. Completed, enrolled 32 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 14, 2012
Enrollment StartSep 1, 2009
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 13.9 years ago

Interventions

post-mastectomy radiation therapy (PMRT)radiation

tissue expander (TE)device

acellular dermal matrix (ADM)device