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

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ClinicalTrials.gov Identifier: NCT02114086
Recruitment Status : Active, not recruiting
First Posted : April 15, 2014
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Münsterlingen

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.

Condition or disease
Adverse Effect of Radiation Therapy

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Study Type : Observational
Actual Enrollment : 163 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prospective Observational Study for Intraoperative Radiotherapy (IORT) of the Breast as a Boost
Actual Study Start Date : January 2013
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : August 31, 2025

Group/Cohort
breast cancer
observation of intraoperative radiotherapy



Primary Outcome Measures :
  1. number of Participants with local recurrence histologically proven [ Time Frame: up to 10 years ]
    Recurrence of breast cancer proven by histology


Secondary Outcome Measures :
  1. 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)

  2. Overall survival [ Time Frame: up to 10 years ]
    The number of Patients who died is assessed.

  3. 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

  4. Cosmesis [ Time Frame: up to 10 years ]
    Cosmesis is assessed by Photographs and evaluated automatically.


Other Outcome Measures:
  1. observation of influence of smoking [ Time Frame: up to 10 years ]
    Patients are asked how many cigarettes they smoke.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women with breast cancer breast-conserving therapy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114086


Locations
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Switzerland
KMünsterlingen
Münsterlingen, Thurgau, Switzerland, 8596
Sponsors and Collaborators
Kantonsspital Münsterlingen
Investigators
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Study Director: Christiane Reuter, Dr. med. Kantonsspital Münsterlingen
Publications:
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Responsible Party: Kantonsspital Münsterlingen
ClinicalTrials.gov Identifier: NCT02114086    
Other Study ID Numbers: ROKSM 01/12
KMünsterlingen ( Other Identifier: KMünsterlingen )
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Keywords provided by Kantonsspital Münsterlingen:
Observational Study
intraoperative Radiation of Breast Cancer
early and late effects of radiation
cosmesis and quality of life