Postoperative Radiation of Patients With Breast Cancer in Extreme Hypofractionation.
NCT ID: NCT05452083
Last Updated: 2022-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2022-08-01
2035-07-30
Brief Summary
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Detailed Description
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In addition, we are planning an accompanying translational research program since hypofractionated schedules are suggested to be more immunogenic in breast cancer.
Secondary objectives therefore are: cosmetic outcome, local tumor control, quality of life, dynamic immune status, importance of tumor infiltrating immune cells, overall survival, disease-free survival, feasibility of breath-hold radiation technique.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* pT-category pT0-3
* complete resection (R0)
* Absence of distant metastasis (M0)
* Absence of contralateral breast cancer/ DCIS
* Karnofsky Performance Score ≥ 60%
* Age ≥ 18 years at time of study entry
* Written informed consent
* Morbus Paget or pathological skin infiltration
* Earlier or synchronous breast cancer
* Pregnant or breast-feeding women
* Increased radiosensitivity or any genetic disposition for increased radiosensitivity, e.g. ataxia telangiectatica
* Judgement by the investigator that the patient is unlikely to comply with study procedures and requirements
18 Years
FEMALE
No
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Claudia Schweizer
Dr. med. Claudia Schweizer
Other Identifiers
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ExtremeHypofractionationBreast
Identifier Type: -
Identifier Source: org_study_id
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