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

September 6, 2022 updated by: Kantonsspital Münsterlingen

Prospective Observational Study for Intraoperative Radiotherapy (IORT) of the Breast as a Boost

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Thurgau
      • Münsterlingen, Thurgau, Switzerland, 8596
        • KMünsterlingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women with breast cancer breast-conserving therapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
breast cancer
observation of intraoperative radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of Participants with local recurrence histologically proven
Time Frame: up to 10 years
Recurrence of breast cancer proven by histology
up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 10 years
Overall survival
Time Frame: up to 10 years
The number of Patients who died is assessed.
up to 10 years
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
up to 10 years
Cosmesis
Time Frame: up to 10 years
Cosmesis is assessed by Photographs and evaluated automatically.
up to 10 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
observation of influence of smoking
Time Frame: up to 10 years
Patients are asked how many cigarettes they smoke.
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Münsterlingen

Investigators

  • Study Director: Christiane Reuter, Dr. med., Kantonsspital Münsterlingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 31, 2019

Study Completion (Anticipated)

August 31, 2025

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 6, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ROKSM 01/12
  • KMünsterlingen (Other Identifier: KMünsterlingen)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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