CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,200 enrolled
Drug / intervention
Adjuvant Radiotherapyradiation
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04783818
NCT04783818N/ACompleted

Multicenter Retrospective Evaluation Study of the Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction

Humanitas Clinical and Research Center·observational·Posted Mar 5, 2021·Updated Mar 9, 2021

In Brief

An observational study evaluating Adjuvant Radiotherapy for Mammaplasty and 3 related conditions. Completed, enrolled 3,200 participants across 1 site.

Detailed Summary

For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life. There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction. Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes. Despite the undoubted cancer benefits, several studies have shown the negative impact of radiotherapy on breast reconstruction. However, there are few studies with a significant number that evaluate the effect of radiotherapy on the three types of reconstruction. In particular, given the extreme variability in clinical approaches, there is no certainty about the best reconstructive timing compared to radiotherapy, the iterations with dermic matrices as well as the usefulness of ancillary procedures such as autologous adipose grafting. The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the effect of radiotherapy on different reconstructive modes.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 5, 2021
Enrollment StartJun 6, 2020
Primary CompletionNov 23, 2020
Study CompletionJan 25, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.3 years ago

Interventions

Adjuvant Radiotherapyradiation

PMRT