CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 80 target
Drug / intervention
Preoperative radiotherapy +1 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/NCT05512286
NCT05512286N/ARecruitingOn TrackUpdated 19mo ago
Long Recruiting

Comparison of Patient-Reported Outcome and Safety Outcomes Between Preoperative and Postmastectomy Radiotherapy in Breast Cancer Patients with Reconstruction of DIEP Flap: a Multicenter,Prospective,Open-label,Randomized Controlled Trial

Fudan University·interventional·Posted Aug 23, 2022·Updated Nov 25, 2024

In Brief

A clinical study evaluating Preoperative radiotherapy and Postmastectomy radiotherapy for Breast Cancer. Currently recruiting, targeting 80 participants across 6 sites.

Detailed Summary

This study is the first prospective randomized study assessing the patient-reported outcomes and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction of deep inferior epigastric perforator(DIEP) flap. Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy. We aimed to explore the feasibility of preoperative radiotherapy followed by DIEP flap reconstruction in patients with breast cancer requiring mastectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesChina

Timeline

N/ARecruiting
20232024202520262027
First PostedAug 23, 2022
Enrollment StartAug 25, 2022
Primary CompletionJul 1, 2026
Study CompletionOct 1, 2027
TodayJul 1, 2026
Enrollment to primary: 3.9 yearsPosted 3.9 years ago

Interventions

Preoperative radiotherapyradiation

Radiotherapy followed by mastectomy and DIEP flap reconstruction

Postmastectomy radiotherapyradiation

Radiotherapy after mastectomy and DIEP flap reconstruction