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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial Breast Irradiation | Active Comparator |
| |
| Whole Breast Irradiation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra-fractionated WBI | Radiation | An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | Assessment of acute toxicity of radiotherapy in two radiotherapy regimens. Acute toxicity will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0 | 1-6 months after RT |
| Late toxicity | Assessment of late toxicity of radiotherapy in two radiotherapy regimens. Acute toxicity will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0 | 6-60 months after RT |
| Measure | Description | Time Frame |
|---|---|---|
| Local-regional control | Any newly suspicious skin change/s or palpable lymph node in the irradiated area that is/are pathologically proved to be locoregional tumor recurrence. | 3, 5 and 10 years |
| Disease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivera Ivanov | Contact | 0214805496 | ivanov.olivera@onk.ns.ac.rs | |
| Marko Bojovic | Contact | bojovic.marko@onk.ns.ac.rs |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Institute of Vojvodina | Recruiting | Novi Sad | Vojvodina | 21204 | Serbia |
The analyzed data from the study will be published in scientific journals. We are prepared to share our data for analysis with researchers from similar studies (previously registered on ClinicalTrials.gov) to compare our results.
The expected time for the publication of the first data is in 3 years (2026).
Contact the researchers via email.
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| Ultra-fractionated PBI | Radiation | 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. |
|
Disease-free survival refers to the time from adjuvant radiotherapy of breast cancer to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death.
| 3, 5 and 10 years |
| Overall Survival | Time from adjuvant radiotherapy to death. | 3, 5 and 10 years |
| Distant metastasis occurrence | The time from adjuvant radiotherapy to the occurrence of distant metastasis. | 3, 5 and 10 years |
| Cosmetic outcome | The Harvard score for breast cosmesis (a 4-grade scale) will be used, which will be independently filled out by both patients and physicians. | 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 | We will use the EORTC QLQ-BR23 questionnaire validated for the Serbian-speaking population to assess the quality of life. | 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. |