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 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT01343459
Eligibility Criteria:
Inclusion Criteria:
* Histological proven invasive breast carcinoma
* Age: ≥ 35 years
* Tumor stage T1-2
* nodal status: N0-1
* Freedom of surgical margins: R0 (both invasive and in situ component), that means no ink on tumors (invasive or in situ) (ago-online.de) .
* Also multifocal disease within the same quadrant with a maximum distance of \< 5 cm
* all grades G1-G3
* Hormonal receptor and Her-2 status: no limitations
* Informed and undersigned consent
Exclusion Criteria:
* In-situ Carcinoma without invasive component
* Age \< 35
* Tumor stage T3,4
* Nodal status \>N1
* if irradiation of regional lymphatics is required
* R1
* Re-excision after IOERT
* Immediately secondary mastectomy (not due to recurrence).
* Multicentricity according to international definition: \> 5 cm distance to each other
* previous radiotherapy to the involved breast
* Karnofsky Index \< 70%
* Mixed connective tissue diseases including rheumatoid Polyarthritis, Thrombangitis obliterans
* Chronic pre-existent lung disease (Lung fibrosis, Pneumokoniosis, late-type Allergies like Farmer lung; Asthma bronchiale, severe Emphysema, COPD III \*)
* Cardiac Co-Morbidity: clinically positive coronary vessel disease, St.p. myocardial infarction, pacemakers and/or defibrillators)
* Distant metastases
* breast size (PTV) \> 2500 ml
* missing written consent
* observed pregnancy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Study:
NCT01343459
Study Brief:
Protocol Section:
NCT01343459