Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)

Breast Cancer Female Clinical Trial

Official title:

Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914831
• Other study ID #: NS-dojka-SRB
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer Female

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.