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Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy

Primary Purpose

Breast Cancer, Radiotherapy Side Effect

Status
Withdrawn
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Simultaneous integrated boost
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Simultaneous integrated boost arm

Arm Description

Outcomes

Primary Outcome Measures

Acute Radiation induced toxicity (grade 2 or higher)
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Acute Radiation induced toxicity (grade 2 or higher)
Toxicity score using Common Terminology for Adverse Events (CTCAE)

Secondary Outcome Measures

Full Information

First Posted
August 25, 2020
Last Updated
October 7, 2022
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT04535895
Brief Title
Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy
Official Title
Simultaneous Integrated Boost (SIB) Technique in the Adjuvant Radiotherapy of Breast Cancer Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Treatment standard has changed
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Radiotherapy Side Effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simultaneous integrated boost arm
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Simultaneous integrated boost
Intervention Description
Adjuvant breast cancer irradiation including simultaneous integrated boost
Primary Outcome Measure Information:
Title
Acute Radiation induced toxicity (grade 2 or higher)
Description
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Time Frame
Measurement at the last 1 day of radiotherapy
Title
Acute Radiation induced toxicity (grade 2 or higher)
Description
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Time Frame
Measurement 3 months after completion of radiotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanja Langsenlehner, MD
Organizational Affiliation
Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22280808
Citation
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.
Results Reference
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Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy

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