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Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability

NCT06382818 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 854

Last updated 2026-03-12

No results posted yet for this study

Summary

Our objective is based on a personalized approach of adjuvant breast radiotherapy by selecting patients according to tumor recurrence and toxicity risk.

Conditions

Interventions

RADIATION

COHORT A

IMRT radiotherapy on whole breast according to the investigator's decision among: * Moderate whole breast hypofractionated RT according to the START B schema with Fixed Field IMRT Technique: 40.05 Gy in 15 daily fractions over 3 weeks and a Sequential boost (+ 16 Gy/8 fr) or (+13.5/5 fr) if applicable. * Extreme whole breast hypofractionated RT according to : * The FAST schema: Once-a-week ultra-HypoRT with Fixed Field IMRT Technique, 28.5 Gy in 5 fractions in 5 weeks * The FAST-Forward schema: Very accelerated course of HypoRT with Fixed Field IMRT Technique, 26 Gy in 5 fractions in 5 consecutive days

RADIATION

COHORT B

Breast radiotherapy according to the investigator's decision among: * External partial VMAT: 40 Gy in 15 fractions to the partial breast only (tumorectomy bed). * Exclusive Brachytherapy: 30.1 Gy in 7 fractions or 32.0 Gy in 8 fractions of high-dose-rate brachytherapy in 5 days or as 50 Gy of pulsed-dose-rate brachytherapy over 5 treatment days. * Whole Breast Normo fractionated IMRT with Fixed Field IMRT Technique: 50 Gy in 25 daily fractions over 5 weeks +/- Sequential (+ 16 Gy/8fr) or SIB (60 Gy/25 fr) treatment for boost if applicable.

RADIATION

COHORT C

Whole breast and nodes Hypofractionated VMAT and a localized simultaneous boost according to the HypoG01 schema protocol: VMAT Technique, 42.3 Gy in 18 fractions on all target volume on 3.5 weeks +/- SIB boost if need (52.2Gy in 18 fractions).

RADIATION

COHORT D

Breast radiotherapy based on available clinical trials: \- Whole Breast and Nodes Hypofractionated VMAT with adaptive treatment (margin reduction): HypoG01 Schema with VMAT Technique, 42.3 Gy in 18 fractions on all target volume over 3.5 weeks +/- SIB boost if need (52.2Gy in 18 fr) In case of patient refusal or technique unavailable, a standard treatment available in the center for this indication will be delivered.

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • AZRIA DAVID · Institut du Cancer de Montpellier - Val d'Aurelle

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-06
Primary Completion
2028-03-06
Completion
2038-03-06

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06382818 on ClinicalTrials.gov