Prospective Assessment of Quality of Life in Patients With Locally Recurrent Breast Cancer and Hyperthermic Radiotherapy
Recruiting · NCT04878666 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital Tuebingen
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- University Hospital Tübingen, Department of Radiation Oncology - Tübingen, Baden-Wurttemberg, Germany