Clinical trial NCT05914831: Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)
Official title: Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer Female
Keywords: Ultra-hypofractionated radiotherapy
Partial breast irradiation
Breast radiotherapy toxicity
Lead sponsor: Oncology Institute of Vojvodina
Sponsor class: OTHER_GOV
First posted: 2023-06-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

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

Primary outcomes:
measure: Acute toxicity
timeFrame: 1-6 months after RT
measure: Late toxicity
timeFrame: 6-60 months after RT
Secondary outcomes:
measure: Local-regional control
timeFrame: 3, 5 and 10 years
measure: Disease-free survival
timeFrame: 3, 5 and 10 years
measure: Overall Survival
timeFrame: 3, 5 and 10 years
measure: Distant metastasis occurrence
timeFrame: 3, 5 and 10 years
measure: Cosmetic outcome
timeFrame: 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.
measure: QoL assessment
timeFrame: 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.
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Oncology Institute of Vojvodina
state: Vojvodina
Study officials:
References: