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| ID | Type | Description | Link |
|---|---|---|---|
| ERIDEK-0045/2019 | Other Identifier | Ethics Committee, Institute of Oncology Ljubljana |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant Radiotherapy With Simultaneous Integrated Boost (SIB) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB) | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Radiation Toxicity (CTCAE) | 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) | From start of radiotherapy up to 3 months after completion of radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology Ljubljana | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Patients with breast cancer after breast-conserving surgery receive adjuvant radiotherapy with a simultaneous integrated boost (SIB) to the tumor bed. Acute and late toxicity outcomes are prospectively recorded.
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| D017437 |
| Skin and Connective Tissue Diseases |