IORT-Boost-Study, Prospective Observational Study for Intraoperative Radiotherapy of the Breast as a Boost
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|ClinicalTrials.gov Identifier: NCT02114086|
Recruitment Status : Active, not recruiting
First Posted : April 15, 2014
Last Update Posted : March 4, 2021
|Condition or disease|
|Adverse Effect of Radiation Therapy|
|Study Type :||Observational|
|Actual Enrollment :||163 participants|
|Official Title:||Prospective Observational Study for Intraoperative Radiotherapy (IORT) of the Breast as a Boost|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||August 31, 2025|
observation of intraoperative radiotherapy
- number of Participants with local recurrence histologically proven [ Time Frame: up to 10 years ]Recurrence of breast cancer proven by histology
- observation of acute and late effects of Radiotherapy [ Time Frame: up to 10 years ]acute effects of Radiotherapy are assessed by Common Toxicity Criteria for Adverse Effects (CTCAE Version 4.0) and late effects of Radiotherapy are assessed by Late Effects Normal Tissue Subjective Objective Management Analysis (LENT-SOMA)
- Overall survival [ Time Frame: up to 10 years ]The number of Patients who died is assessed.
- Quality of life [ Time Frame: up to 10 years ]Quality of life is assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQ) cancer modul (C30) EORTC-QLQ-C30 version 3.0 and breast cancer modul (BR23) EORTC-QLQ-BR23
- Cosmesis [ Time Frame: up to 10 years ]Cosmesis is assessed by Photographs and evaluated automatically.
- observation of influence of smoking [ Time Frame: up to 10 years ]Patients are asked how many cigarettes they smoke.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114086
|Münsterlingen, Thurgau, Switzerland, 8596|
|Study Director:||Christiane Reuter, Dr. med.||Kantonsspital Münsterlingen|