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

NANot yet recruitingINTERVENTIONAL
Enrollment

854

Participants

Timeline

Start Date

March 6, 2025

Primary Completion Date

March 6, 2028

Study Completion Date

March 6, 2038

Conditions
Breast Cancer
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."

Trial Locations (1)

Unknown

Institut Du Cancer de Montpellier, Montpellier

All Listed Sponsors
lead

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER