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:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT00796120
Eligibility Criteria:
Inclusion Criteria:
* Pathological diagnosis of translocation-related sarcomas (TRS) including the following subtypes: alveolar soft part sarcoma, angiomatoid fibrous histiocytoma, clear cell sarcoma, desmoplastic small round cell tumor, low grade endometrial stromal sarcoma (prior hormone therapy allowed), low grade fibromyxoid sarcoma, myxoid chondrosarcoma, myxoid/round cell liposarcoma (MRCL) and synovial sarcoma
* Participants must have unresectable locally advanced or metastatic progressive disease prior to enrolment
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2
* Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) within normal limits according to institutional standards, as shown by echocardiography or scintigraphy multiple-gated acquisition scan \[MUGA\]
* Measurable disease as defined by the radiological (computed tomography \[CT\] scan and magnetic resonance imaging \[MRI\]) Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) guidelines
Exclusion Criteria:
* Known hypersensitivity to any components of the intravenous formulation of trabectedin or the comparators
* Prior chemotherapy treatment or irradiation of the lesion if only one target lesion is available
* Brain metastases and/or leptomeningeal metastases, even if treated
* Pregnant or lactating women or men and women of reproductive potential who are not using effective contraceptive methods
* History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for five years or more
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00796120
Study Brief:
Protocol Section:
NCT00796120