Toxicity Outcomes of Simultaneous Integrated Boost in Adjuvant Breast Radiotherapy Acronym (SIB)
February 12, 2026 updated by: Institute of Oncology Ljubljana
Toxicity Outcomes of Simultaneous Integrated Boost as Part of Adjuvant Radiotherapy in Breast Cancer Patients After Breast-Conserving Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ljubljana, Slovenia, 1000
- Institute of Oncology Ljubljana
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Female patients with histologically confirmed breast cancer
- Status post breast-conserving surgery (lumpectomy)
- Planned adjuvant whole-breast radiotherapy with simultaneous integrated boost (SIB) to the tumor bed
- Age ≥ 18 years
- Ability to provide informed consent
Exclusion Criteria:
- Prior radiotherapy to the breast or thoracic region
- Mastectomy (no breast-conserving surgery)
- Pregnancy or breastfeeding
- Inability to complete planned radiotherapy or follow-up assessments
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adjuvant Radiotherapy With Simultaneous Integrated Boost (SIB)
Breast cancer patients treated with breast-conserving surgery receive adjuvant radiotherapy to the whole breast with a simultaneous integrated boost (SIB) to the tumor bed, using either standard fractionation or hypofractionation.
Acute and late toxicity outcomes are prospectively recorded.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acute Radiation Toxicity (CTCAE)
Time Frame: From start of radiotherapy up to 3 months after completion of radiotherapy
|
Incidence and severity of acute radiotherapy-related toxicity assessed during treatment and shortly after completion, graded according to Common Terminology Criteria for Adverse Events (CTCAE).
|
From start of radiotherapy up to 3 months after completion of radiotherapy
|
|
Acute Radiation Toxicity (CTCAE)
Time Frame: From start of radiotherapy up to 3 months after completion of radiotherapy
|
From start of radiotherapy up to 3 months after completion of radiotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
February 6, 2026
First Submitted That Met QC Criteria
February 6, 2026
First Posted (Actual)
February 12, 2026
Study Record Updates
Last Update Posted (Actual)
February 17, 2026
Last Update Submitted That Met QC Criteria
February 12, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OI-BREAST-SIB-2019
- ERIDEK-0045/2019 (Other Identifier: Ethics Committee, Institute of Oncology Ljubljana)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.