Status:
RECRUITING
Prospective Assessment of Quality of Life in Patients With Locally Recurrent Breast Cancer and Hyperthermic Radiotherapy
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
Prospective assessment of Quality of Life in patients with locally recurrent breast cancer after close R0, R1 or R2 resection or local inoperability and hyperthermic radiotherapy.
Detailed Description
This prospective monocentric trial evaluates the health-related Quality of Life in patients with local recurrence of Breast cancer after close R0, R1 or R2 resection or local inoperability during and ...
Eligibility Criteria
Inclusion
- Histologically confirmed local recurrence of breast cancer after close resection (≤1mm Resection margin), R1 or R2 resection respectively inoperable recurrence of the chest wall
- age ≥18 Jahre
- ECOG PS 0-2
- Estimated life expectancy more than 2 years
- Informed consent
Exclusion
- Extensive distant metastases that have an estimated life expectancy of \<2a
- Heart disease: severe heart failure (NHYA III / IV), coronary heart disease, state after Myocardial infarction within the last 6 months), AV block III °
- Cardiac pacemaker
- Second malignancy (except cervical carcinomas in situ, local controlled basaliomas, superficial bladder carcinomas (Ta, Tis, T1) or other carcinomas that have lasted more than 5 years behind and have been treated curatively)
- Pregnancy or breastfeeding
- Implanted port on the side to be treated in the Hyperthermia field (located contralateral is not an exclusion criteria)
- Subclavian vein thrombosis less than \<6 months behind
- Other circumstances that preclude hyperthermia
- Circumstances that conflict with regular follow-up care
- Transplanted organs
- Other implants of the ipsilateral chest wall
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04878666
Start Date
August 1 2020
End Date
December 31 2026
Last Update
May 7 2021
Active Locations (1)
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1
University Hospital Tübingen, Department of Radiation Oncology
Tübingen, Baden-Wurttemberg, Germany, 72076