Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Partial Breast Irradiation
|
Radiation: Ultra-fractionated radiation therapy
An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast or the part of the breast where the tumor was located.
|
| Experimental: Whole Breast Irradiation
|
Radiation: Ultra-fractionated radiation therapy
An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast or the part of the breast where the tumor was located.
|
Outcome Measures
Primary Outcome Measures
- Acute toxicity [1-6 months after RT]
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
- Late toxicity [6-60 months after RT]
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
Secondary Outcome Measures
- Local-regional control [3, 5 and 10 years]
Any newly suspicious skin change/s or palpable lymph node in the irradiated area that is/are pathologically proved to be locoregional tumor recurrence.
- Disease-free survival [3, 5 and 10 years]
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.
- Overall Survival [3, 5 and 10 years]
Time from adjuvant radiotherapy to death.
- Distant metastasis occurrence [3, 5 and 10 years]
The time from adjuvant radiotherapy to the occurrence of distant metastasis.
- Cosmetic outcome [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.]
The Harvard score for breast cosmesis (a 4-grade scale) will be used, which will be independently filled out by both patients and physicians.
- QoL assessment [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.]
We will use the EORTC QLQ-BR23 questionnaire validated for the Serbian-speaking population to assess the quality of life.
Eligibility Criteria
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
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Histological grade G1 or G2
Exclusion Criteria:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oncology Institute of Vojvodina | Novi Sad | Vojvodina | Serbia | 21204 |
Sponsors and Collaborators
- Oncology Institute of Vojvodina
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NS-dojka-SRB