Breast Cancer Clinical Trial
Official title:
Simultaneous Integrated Boost (SIB) Technique in the Adjuvant Radiotherapy of Breast Cancer Patients.
| Verified date | October 2022 |
| Source | Medical University of Graz |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Adjuvant radiotherapy after breast conserving surgery has been shown to improve both local control and overall survival. Dose escalation of the tumor bed by addition of a boost after whole breast radiotherapy reduces the risk of local recurrence in invasive breast cancer. Simultaneous integrated boost (SIB) techniques have been shown to provide more conformal treatment plans than conventional sequential boost, in addition, SIB enables a reduction in the overall treatment time by 1 week compared to conventional boost techniques. The proposed study is aimed at evaluating radiation-induced toxicity in patients treated with breast-conserving surgery in combination with radiotherapy using SIB technique.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | August 31, 2025 |
| Est. primary completion date | August 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Invasive breast cancer or ductal carcinoma in situ - Breast conserving surgery - Complete tumor resection - Treatment with adjuvant radiotherapy of the breast - Indication for boost Irradiation - Given informed consent Exclusion Criteria: - Incomplete tumor resection - Mastectomy - Distant metastases at diagnosis - Unable to give informed consent |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Graz | Graz |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Graz |
Austria,
Hurkmans CW, Dijckmans I, Reijnen M, van der Leer J, van Vliet-Vroegindeweij C, van der Sangen M. Adaptive radiation therapy for breast IMRT-simultaneously integrated boost: three-year clinical experience. Radiother Oncol. 2012 May;103(2):183-7. doi: 10.1016/j.radonc.2011.12.014. Epub 2012 Jan 24. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Acute Radiation induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | Measurement at the last 1 day of radiotherapy | |
| Primary | Acute Radiation induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | Measurement 3 months after completion of radiotherapy |
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