Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT04878666
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04878666
Study Brief:
Protocol Section:
NCT04878666