Actively Recruiting

Phase 2
Age: 50Years +
FEMALE
NCT05914831

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

Led by Oncology Institute of Vojvodina · Updated on 2023-07-03

100

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Breast-conserving surgery
  • Invasive ductal carcinoma
  • Age 250
  • Tumor size 253 cm
  • R0 resection
  • Unicentric/unifocal carcinoma or multifocal carcinoma within 2 cm of the primary neoplasm
  • pN0 (sentinel lymph node biopsy or axillary lymph node dissection performed), N1mi
  • Hormone receptor status - any
  • Histological grade G1 or G2
Not Eligible

You will not qualify if you...

  • Neoadjuvant systemic therapy
  • Triple-negative breast cancer (TNBC)
  • Extensive intraductal component (EIC)
  • Lymphovascular invasion (LVI)
  • Associated ductal carcinoma in situ (DCIS) larger than 2.5 cm or of high nuclear grade

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Oncology Institute of Vojvodina

Novi Sad, Vojvodina, Serbia, 21204

Actively Recruiting

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Research Team

O

Olivera Ivanov

CONTACT

M

Marko Bojovic

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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