IORT-Boost-Study, Prospective Observational Study for Intraoperative Radiotherapy of the Breast as a Boost

Active, not recruiting

• Conditions: Adverse Effect of Radiation Therapy

• Registration Number: NCT02114086
• Lead Sponsor: Kantonsspital Münsterlingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2014-04-14
• Study First Posted: 2014-04-15
• Primary Completion: 2019-12-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-07
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 163

Inclusion Criteria

• 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

Exclusion Criteria

• missing written informed consent
• lack of compliance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of Participants with local recurrence histologically proven	up to 10 years	Recurrence of breast cancer proven by histology

Secondary Outcome Measures

Name	Time	Method
Quality of life	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	up to 10 years	Cosmesis is assessed by Photographs and evaluated automatically.
Overall survival	up to 10 years	The number of Patients who died is assessed.
observation of acute and late effects of Radiotherapy	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)

Trial Locations

Locations (1)

KMünsterlingen; 🇨🇭 Münsterlingen, Thurgau, Switzerland