Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Oncology Institute of Vojvodina
Novi Sad, Vojvodina, Serbia, 21204
Actively Recruiting
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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