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Trial Title:
Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)
NCT ID:
NCT05914831
Condition:
Breast Cancer Female
Conditions: Keywords:
Ultra-hypofractionated radiotherapy
Partial breast irradiation
Breast radiotherapy toxicity
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Ultra-fractionated WBI
Description:
An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to
the whole breast where the tumor was located.
Arm group label:
Whole Breast Irradiation
Intervention type:
Radiation
Intervention name:
Ultra-fractionated PBI
Description:
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.
Arm group label:
Partial Breast Irradiation
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.
Detailed description:
Radiation therapy should ideally start 6-8 weeks after breast-conserving surgery but no
later than 12 weeks after the surgery.
If adjuvant chemotherapy has been administered, it is recommended to start radiation
therapy three weeks after chemotherapy (optionally, it can be completed before beginning
chemotherapy).
The radiation therapy procedure follows the existing clinical protocol for breast
radiotherapy. For radiation therapy planning, the patient is positioned supine using
immobilization devices (such as a wing board or similar) to ensure daily reproducibility
within a range of 5 mm. The clinical target volume (CTV) is delineated according to the
recommendations of the Danish Breast Cancer Cooperative Group (DBCG) and the European
Society for Radiotherapy and Oncology (ESTRO).
A total dose of 26Gy in 5 fractions every working day using the Volumetric Modulated Arc
Therapy (VMAT) technique. Daily portal images are obtained, and a breathing control
protocol is applied based on clinical assessment (for left breast radiation therapy,
active breath control is used - in deep inspiration or respiratory gating).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Neoadjuvant systemic therapy
- TNBC (triple-negative breast cancer)
- Extensive intraductal component (EIC)
- Lymphovascular invasion (LVI)
- associated DCIS > 2.5 cm in size or high nuclear grade
Gender:
Female
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Oncology Institute of Vojvodina
Address:
City:
Novi Sad
Zip:
21204
Country:
Serbia
Status:
Recruiting
Contact:
Last name:
Olivera Ivanov
Phone:
0214805496
Email:
ivanov.olivera@onk.ns.ac.rs
Contact backup:
Last name:
Marko Bojovic
Email:
bojovic.marko@onk.ns.ac.rs
Start date:
June 1, 2023
Completion date:
May 31, 2033
Lead sponsor:
Agency:
Oncology Institute of Vojvodina
Agency class:
Other
Source:
Oncology Institute of Vojvodina
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05914831
