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

Adverse Effect of Radiation Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02114086
• Other study ID #: ROKSM 01/12
• Secondary ID: KMünsterlingen
• Status: Active, not recruiting
• Start date: January 2013
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2022
• Source: Kantonsspital Münsterlingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 163
• Est. completion date: August 31, 2025
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Effect of Radiation Therapy

Locations

Country	Name	City	State
Switzerland	KMünsterlingen	Münsterlingen	Thurgau

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Münsterlingen

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Wárlám-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. Epub 2007 Jun 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	observation of influence of smoking	Patients are asked how many cigarettes they smoke.	up to 10 years
Primary	number of Participants with local recurrence histologically proven	Recurrence of breast cancer proven by histology	up to 10 years
Secondary	observation of acute and late effects of Radiotherapy	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
Secondary	Overall survival	The number of Patients who died is assessed.	up to 10 years
Secondary	Quality of life	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
Secondary	Cosmesis	Cosmesis is assessed by Photographs and evaluated automatically.	up to 10 years