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Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI) - Trial NCT05914831

Access comprehensive clinical trial information for NCT05914831 through Pure Global AI's free database. This Phase 2 trial is sponsored by Oncology Institute of Vojvodina and is currently Recruiting. The study focuses on Breast Cancer Female. Target enrollment is 100 participants.

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NCT05914831
Phase 2
Recruiting
radiation
Trial Details
ClinicalTrials.gov โ€ข NCT05914831
View on ClinicalTrials.gov
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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

Study Focus

Breast Cancer Female

Ultra-fractionated WBI

Interventional

radiation

Sponsor & Location

Oncology Institute of Vojvodina

Novi Sad, Serbia

Timeline & Enrollment

Phase 2

Jun 01, 2023

May 31, 2033

100 participants

Primary Outcome

Acute toxicity,Late toxicity

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.

ICD-10 Classifications

Malignant neoplasm: Breast, unspecified
Malignant neoplasm of breast
Malignant neoplasm of breast
Carcinoma in situ of breast, unspecified
Personal history of malignant neoplasm of breast

Data Source

ClinicalTrials.gov

NCT05914831

Non-Device Trial