IORT-Boost-Study, Prospective Observational Study for Intraoperative Radiotherapy of the Breast as a Boost
Prospective Observational Study for Intraoperative Radiotherapy (IORT) of the Breast as a Boost
2 other identifiers
observational
163
1 country
1
Brief Summary
In this study the investigators observe the investigation, whether the new method for Boost-Irradiation with the Intrabeam Device of Zeiss Germany influences local recurrence, acute and late effects of Radiotherapy, overall survival, quality of life and cosmesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 4, 2013
CompletedFirst Posted
Study publicly available on registry
April 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedSeptember 7, 2022
September 1, 2022
7 years
September 4, 2013
September 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of Participants with local recurrence histologically proven
Recurrence of breast cancer proven by histology
up to 10 years
Secondary Outcomes (4)
observation of acute and late effects of Radiotherapy
up to 10 years
Overall survival
up to 10 years
Quality of life
up to 10 years
Cosmesis
up to 10 years
Other Outcomes (1)
observation of influence of smoking
up to 10 years
Study Arms (1)
breast cancer
observation of intraoperative radiotherapy
Eligibility Criteria
women with breast cancer breast-conserving therapy
You may qualify if:
- women with histologically proven unifocal ductal-invasive or other histology of breast-cancer, size of tumor \< or = 3.5 cm
- written informed consent
- ability to cooperate
- full legal capability
You may not qualify if:
- missing written informed consent
- lack of compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KMünsterlingen
Münsterlingen, Thurgau, 8596, Switzerland
Related Publications (1)
Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18.
PMID: 17577015BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christiane Reuter, Dr. med.
Kantonsspital Münsterlingen
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2013
First Posted
April 15, 2014
Study Start
January 1, 2013
Primary Completion
December 31, 2019
Study Completion
August 31, 2025
Last Updated
September 7, 2022
Record last verified: 2022-09