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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05914831
Other study ID # NS-dojka-SRB
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 1, 2023
Est. completion date May 31, 2033

Study information

Verified date June 2023
Source Oncology Institute of Vojvodina
Contact Olivera Ivanov
Phone 0214805496
Email ivanov.olivera@onk.ns.ac.rs
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 31, 2033
Est. primary completion date May 31, 2026
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Serbia Oncology Institute of Vojvodina Novi Sad Vojvodina

Sponsors (1)

Lead Sponsor Collaborator
Oncology Institute of Vojvodina

Country where clinical trial is conducted

Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary 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
Secondary Disease-free survival 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
Secondary Overall Survival Time from adjuvant radiotherapy to death. 3, 5 and 10 years
Secondary Distant metastasis occurrence The time from adjuvant radiotherapy to the occurrence of distant metastasis. 3, 5 and 10 years
Secondary 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.
Secondary 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.
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