Study Stopped
Treatment standard has changed
Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2020
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2020
CompletedFirst Submitted
Initial submission to the registry
August 25, 2020
CompletedFirst Posted
Study publicly available on registry
September 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedOctober 12, 2022
October 1, 2022
2.4 years
August 25, 2020
October 7, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Acute Radiation induced toxicity (grade 2 or higher)
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Measurement 3 months after completion of radiotherapy
Study Arms (1)
Simultaneous integrated boost arm
EXPERIMENTALInterventions
Adjuvant breast cancer irradiation including simultaneous integrated boost
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Incomplete tumor resection
- Mastectomy
- Distant metastases at diagnosis
- Unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Graz
Graz, 8036, Austria
Related 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.
PMID: 22280808BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tanja Langsenlehner, MD
Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2020
First Posted
September 2, 2020
Study Start
April 16, 2020
Primary Completion
August 31, 2022
Study Completion
August 31, 2025
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share