Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy

Not Applicable

Withdrawn

• Conditions: Radiotherapy Side Effect; Breast Cancer

• Registration Number: NCT04535895
• Lead Sponsor: Medical University of Graz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-16
• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-02
• Primary Completion: 2022-08-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-12
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acute Radiation induced toxicity (grade 2 or higher)	Measurement 3 months after completion of radiotherapy	Toxicity score using Common Terminology for Adverse Events (CTCAE)

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria