CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,150 enrolled
Drug / intervention
Pre reconstruction Radiotherapyradiation
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/NCT04854525
NCT04854525N/ACompleted

Multicenter Retrospective Evaluation Study of Pre-reconstruction Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction

Humanitas Clinical and Research Center·observational·Posted Apr 22, 2021·Updated Apr 22, 2021

In Brief

An observational study evaluating Pre reconstruction Radiotherapy for Mammaplasty and 3 related conditions. Completed, enrolled 2,150 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. As a consequence, plastic surgeons come into contact with more patients with a history of irradiation of their breasts than ever before. However, there are few studies with a significant number that evaluate the effect of pre-reconstruction radiotherapy on the three types of reconstruction. The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the impact of breast prior irradiation on the outcome of prosthetic reconstruction.

Study Details

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

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 22, 2021
Enrollment StartJun 6, 2020
Primary CompletionNov 23, 2020
Study CompletionJan 25, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.2 years ago

Interventions

Pre reconstruction Radiotherapyradiation

Previous PMRT