Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02114086
NCT02114086
Active, not recruiting
Not Applicable

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

Kantonsspital Münsterlingen1 site in 1 country163 target enrollmentJanuary 2013
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsAdverse Effect of Radiation Therapy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adverse Effect of Radiation Therapy
Sponsor
Kantonsspital Münsterlingen
Enrollment
163
Locations
1
Primary Endpoint
number of Participants with local recurrence histologically proven
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
August 31, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

number of Participants with local recurrence histologically proven

Time Frame: up to 10 years

Recurrence of breast cancer proven by histology

Secondary Outcomes

  • Quality of life(up to 10 years)
  • Cosmesis(up to 10 years)
  • Overall survival(up to 10 years)
  • observation of acute and late effects of Radiotherapy(up to 10 years)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Observational Study to Assess Intravitreal Aflibercept Injections Used in a "Treat and Extend" Regimen in Treatment-naïve Wet Age-related Macular Degeneration PatientsWet Age-related Macular Degeneration
NCT03382587Bayer163
Completed
Phase 4
PAIN - Postoperative Analgesia INvestigationPostoperative Pain
NCT02111746The University of Texas Health Science Center, Houston350
Completed
Not Applicable
Outcomes of an Intraoperative Bispectral Index MonitorAnesthesia
NCT03052543Boston Children's Hospital60
Withdrawn
Phase 4
Intraoperative ICG for Systemic SclerosisSystemic Sclerosis
NCT03155464Duke University
Recruiting
Not Applicable
Study Protocol to Evaluate Clinical and Imaging Results of Knee Fresh Osteochondral AllograftsOsteochondral Defect
NCT04236492Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau40