Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy

October 7, 2022 updated by: Medical University of Graz

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simultaneous integrated boost arm
Radiation: Simultaneous integrated boost
Adjuvant breast cancer irradiation including simultaneous integrated boost

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Radiation induced toxicity (grade 2 or higher)
Time Frame: Measurement at the last 1 day of radiotherapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Measurement at the last 1 day of radiotherapy
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)
Measurement 3 months after completion of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Tanja Langsenlehner, MD, Medical University of Graz, Dept. of Therapeutic Radiology and Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2020

Primary Completion (Anticipated)

August 31, 2022

Study Completion (Anticipated)

August 31, 2025

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1094/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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