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

Status Recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Breast Cancer Female

Clinical Trial Details

NCT number	NCT05914831
Study type	Interventional
Source	Oncology Institute of Vojvodina
Contact	Olivera Ivanov
Phone	0214805496
Email	ivanov.olivera@onk.ns.ac.rs
Status	Recruiting
Phase	Phase 2
Start date	June 1, 2023
Completion date	May 31, 2033

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms