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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: f
View:

• Breast-conserving surgery

• Invasive ductal carcinoma

• Age ≥ 50

• Tumor size ≤ 3 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

Locations
Other Locations
Serbia
Oncology Institute of Vojvodina
RECRUITING
Novi Sad
Contact Information
Primary
Olivera Ivanov
ivanov.olivera@onk.ns.ac.rs
0214805496
Backup
Marko Bojovic
bojovic.marko@onk.ns.ac.rs
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2033-05-31
Participants
Target number of participants: 100
Treatments
Active_comparator: Partial Breast Irradiation
Experimental: Whole Breast Irradiation
Related Therapeutic Areas
Sponsors
Leads: Oncology Institute of Vojvodina

This content was sourced from clinicaltrials.gov