CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 519 enrolled
Drug / intervention
tumorectomy with axillary dissection (sentinel lymph node) +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.

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Search/NCT04414202
NCT04414202N/AActive

Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis

Institut du Cancer de Montpellier - Val d'Aurelle·observational·Posted Jun 4, 2020·Updated Jun 23, 2026

In Brief

An observational study evaluating tumorectomy with axillary dissection (sentinel lymph node) and per-operative partial irradiation for Invasive Breast Cancer and Breast-conserving Surgery. Active but no longer recruiting, targeting 519 participants across 1 site.

Detailed Summary

Due to screening, T1N0 early-stage breast cancer now accounts for more than 50% of the tumors diagnosed in France. The prognosis of these tumors is good, even excellent in women ≥ 65 years of age, with specific survival of 98% at 5 years. The treatment of these tumors combines breast-conserving surgery and external whole breast irradiation for 6.5 weeks. A true de-escalation of treatment is taking place with these tumors, both surgically and medically. Surgery therefore now prefers breast-conserving methods in combination with exeresis of the sentinel lymph node only. In the same way, in many international studies, radiotherapy has been evaluating the possibility of reducing both: * the irradiation volume at the excision site (partial irradiation) * the duration of this irradiation (accelerated radiotherapy) Between 2004 and 2007, the CRLC \[Regional Anti-Cancer Center\] evaluated the feasibility and the oncological results of intra-operative partial irradiation via a phase II study in women 65 years of age and older with T1N0M0 hormone-sensitive tumors with a good prognosis. From 2010 to 2013, the ICM carried out an observational study of these tumors with an excellent prognosis. In July 2009, the American Society for Radiation Oncology (ASTRO) published a consensus statement with specific recommendations and indications for accelerated partial breast irradiation (APBI). This APBI technique has been developing in France over the past 5 years within the framework of clinical studies and in compliance with the 2012 recommendations of the French National Cancer Institute. This APBI can be given by 3D external radiotherapy or, as in this study, by intra-operative radiotherapy (IORT) in order to obtain optimal precision and spare as much of the surrounding healthy tissue as possible. The Investigator therefore propose a cohort study to prospectively analyze the results of this technique applied to the indications strictly defined by the ASTRO.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/AActive
2010201120122013201420152016201720182019202020212022202320242025202620272028202920302031
First PostedJun 4, 2020
Enrollment StartDec 15, 2009
Primary CompletionOct 16, 2023
Study CompletionDec 1, 2030
TodayJul 2, 2026
Enrollment to primary: 13.8 yearsPosted 6.1 years ago

Interventions

tumorectomy with axillary dissection (sentinel lymph node)procedure

All patients will have local excision of the primary tumor following appropriate clinical work-up. Surgery will be done according to usual local practice with a complete excision of the tumor. The aim of the local excision should be to achieve a minimum free margin of 2 mm whilst maintaining a good cosmetic outcome.

per-operative partial irradiationradiation

20 Gy of per-operative partial irradiation at the tumor site during the surgery