CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 66 enrolled
Drug / intervention
tumorectomy +1 moreprocedure
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/NCT02386371
NCT02386371N/ACompleted
CompareCT.gov

Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma

Institut du Cancer de Montpellier - Val d'Aurelle·interventional·Posted Mar 11, 2015·Updated Feb 6, 2025

In Brief

A clinical study evaluating tumorectomy and Intra Operative Radiotherapy for Breast Carcinoma. Completed, enrolled 66 participants across 8 sites.

Detailed Summary

The investigators propose a prospective, multicenter, single arm Phase II design to evaluate the feasibility of repeated breast-conserving surgery combined with re- irradiation using IORT after local recurrence of breast carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Carcinoma
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 11, 2015
Enrollment StartMar 1, 2014
Primary CompletionJun 12, 2020
Study CompletionSep 18, 2023
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 11.3 years ago

Interventions

tumorectomyprocedure

Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.

Intra Operative Radiotherapyradiation

After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure