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RECRUITING
NCT07835139
NA

Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based breast reconstruction. The primary objective is to evaluate whether hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy regarding the rate of unplanned reoperation.

Official title: Outcomes of Hypofractionated Versus Conventionally Fractionated Radiotherapy After Mastectomy and Implant-Based Reconstruction: A Prospective, Randomized Controlled, Non-Inferiority Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

534

Start Date

2026-10

Completion Date

2035-10

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

RADIATION

ConvRT

50Gy/25Fx, 2Gy/Fx, once daily

RADIATION

HypoRT

42.56Gy/16Fx, 2.66Gy/Fx, once daily

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China