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 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT01498835
Eligibility Criteria:
Inclusion Criteria:
* histologically proven soft tissue sarcoma of any histology but GIST, Angiosarcoma, dermatofibrosarcoma protuberans, Ewing Sarcoma or Embryonal Rhabdomyosarcoma
* patients with primary tumors OR with local recurrences who did not receive prior radiation therapy OR with solitary metastatic lesions may be included
* complete resection after neoadjuvant treatment is expected
* age of 18 or older
* ECOG performance score 0 or 1
* normal organ and bone marrow function
* ability to give written informed consent
Exclusion Criteria:
* medication with inhibitors or inducers of CYP3A4
* prior therapy with tyrosine kinase inhibitors or conventional chemotherapy within 4 weeks before study inclusion
* history of myocardial infarction, stroke or thromboembolic events
* clinical signs of heart failure (NYHA 3 or 4)
* anticoagulation with Vitamin K antagonists
* acquired or hereditary coagulopathy
* uncontrolled hypertension
* uncontrolled intercurrent illness
* women who are pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01498835
Study Brief:
Protocol Section:
NCT01498835