Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultra-fractionated WBI, Ultra-fractionated PBI.
- Who it may be relevant to
- Registry conditions: Breast Cancer Female. Basic parameters: from 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Serbia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial
Overview
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).
Interventions
- Radiation Ultra-fractionated WBI
An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located. - Radiation Ultra-fractionated PBI
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.
Primary outcome measures
- Acute toxicity [Time frame: 1-6 months after RT]
- Late toxicity [Time frame: 6-60 months after RT]
Secondary outcome measures (6)
- Local-regional control [Time frame: 3, 5 and 10 years]
- Disease-free survival [Time frame: 3, 5 and 10 years]
- Overall Survival [Time frame: 3, 5 and 10 years]
- Distant metastasis occurrence [Time frame: 3, 5 and 10 years]
- Cosmetic outcome [Time frame: at baseline, during the radiotherapy, immediately after radiotherapy termination and then in the first 2 years every 3 months, in the 4th and 5th year every 6 months and after 5 years once per year.]
- QoL assessment [Time frame: at baseline, during the radiotherapy, immediately after radiotherapy termination and then in the first 2 years every 3 months, in the 4th and 5th year every 6 months and after 5 years once per year.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Serbia · 1 center
- Oncology Institute of Vojvodina — Novi Sad
Identifiers
NCT: NCT05914831 · NS-dojka-SRB