RecruitingPhase 2NCT05914831

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

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

Sponsor

Oncology Institute of Vojvodina

Enrollment

100 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Female

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.

Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation approaches after breast-conserving surgery (lumpectomy): treating the whole breast with a shorter, higher-dose schedule (ultra-hypofractionation) versus treating only the area where the tumor was removed (partial breast irradiation). **You may be eligible if...** - You are 50 or older - You had a lumpectomy for invasive ductal breast carcinoma - Your tumor was 3 cm or smaller and fully removed - No cancer was found in your lymph nodes - Your cancer is hormone receptor-positive **You may NOT be eligible if...** - You are under 50 - Your tumor was larger than 3 cm or not fully removed - Cancer was found in multiple separate areas of the breast - You have had previous radiation to that breast - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONUltra-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.

RADIATIONUltra-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

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NCT05914831

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