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

NCT ID: NCT02114086

Last Updated: 2022-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2025-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adverse Effect of Radiation Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

breast cancer

observation of intraoperative radiotherapy

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kantonsspital Münsterlingen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christiane Reuter, Dr. med.

Role: STUDY_DIRECTOR

Kantonsspital Münsterlingen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

KMünsterlingen

Münsterlingen, Thurgau, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17577015 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KMünsterlingen

Identifier Type: OTHER

Identifier Source: secondary_id

ROKSM 01/12

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

IORT-Breast at Medical Center Navicent Health
NCT04595435 ACTIVE_NOT_RECRUITING
Concurrent Boost Radiotherapy
NCT00981864 COMPLETED PHASE2