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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02114086

Enrollment

163

Registered

2014-04-15

Start date

2013-01-31

Completion date

2025-08-31

Last updated

2022-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effect of Radiation Therapy

Keywords

Observational Study, intraoperative Radiation of Breast Cancer, early and late effects of radiation, cosmesis and quality of life

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)
Overall survival	up to 10 years	The number of Patients who died is assessed.
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.

Other

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

Countries

Switzerland

Outcome results