Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy

Breast Cancer Clinical Trial

Official title:

Simultaneous Integrated Boost (SIB) Technique in the Adjuvant Radiotherapy of Breast Cancer Patients.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04535895
• Other study ID #: 1094/2020
• Status: Withdrawn
• Phase: N/A
• Start date: April 16, 2020
• Est. completion date: August 31, 2025

Study information

• Verified date: October 2022
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiotherapy Side Effect

Intervention

Radiation:
• Simultaneous integrated boost
Adjuvant breast cancer irradiation including simultaneous integrated boost

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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

Outcome

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