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Clinical Trials/NCT04535895
NCT04535895
Withdrawn
Not Applicable

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

Medical University of Graz1 site in 1 countryApril 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Medical University of Graz
Locations
1
Primary Endpoint
Acute Radiation induced toxicity (grade 2 or higher)
Status
Withdrawn
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 16, 2020
End Date
August 31, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Medical University of Graz
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Acute Radiation induced toxicity (grade 2 or higher)

Time Frame: Measurement 3 months after completion of radiotherapy

Toxicity score using Common Terminology for Adverse Events (CTCAE)

Study Sites (1)

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