NCT07407192

Toxicity Outcomes of Simultaneous Integrated Boost in Adjuvant Breast Radiotherapy Acronym

Toxicity Outcomes of Simultaneous Integrated Boost as Part of Adjuvant Radiotherapy in Breast Cancer Patients After Breast-Conserving Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective study systematically evaluates toxicity outcomes in breast cancer patients treated with adjuvant radiotherapy using the simultaneous integrated boost (SIB) technique after breast-conserving surgery. The aim is to monitor acute and late treatment-related side effects during implementation of this radiotherapy approach and to compare institutional toxicity outcomes with published data in the literature.

Detailed description

Breast cancer patients undergoing breast-conserving surgery are treated with adjuvant radiotherapy using either standard fractionation or hypofractionation combined with a simultaneous integrated boost (SIB) to the tumor bed. This prospective study includes systematic collection and grading of acute and late radiation-related toxicity outcomes in order to evaluate the safety of the implemented protocol and to assess whether toxicity rates are comparable to those reported in published clinical studies. The results will support optimization and quality assurance of the radiotherapy technique in routine clinical practice.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB)	Adjuvant whole-breast radiotherapy after breast-conserving surgery with a simultaneous integrated boost (SIB) dose delivered to the tumor bed during the same treatment sessions. Treatment is delivered using either standard fractionation or hypofractionation, according to institutional protocol.

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-12-31
• Completion: 2024-12-31
• First posted: 2026-02-12
• Last updated: 2026-02-17

Locations

1 site across 1 country: Slovenia