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RECRUITING
NCT05914831
PHASE2

Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)

Sponsor: Oncology Institute of Vojvodina

View on ClinicalTrials.gov

Summary

Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions. The study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.

Official title: Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial

Key Details

Gender

FEMALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-06-01

Completion Date

2033-05-31

Last Updated

2023-07-03

Healthy Volunteers

No

Interventions

RADIATION

Ultra-fractionated WBI

An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located.

RADIATION

Ultra-fractionated PBI

An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the part of the breast where the tumor was located.

Locations (1)

Oncology Institute of Vojvodina

Novi Sad, Vojvodina, Serbia