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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT01426633
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically confirmed L-sarcomas (leiomyosarcoma and liposarcoma)
* Measurable disease according to RECIST 1.1
* Any treatment line except adjuvant setting: evidence of primary metastatic situation or disease progression within the last 6 months (based on RECIST 1.1) in computed tomography or magnetic resonance imaging
* Any prior treatment possible
* Age \>= 18 years
* WHO PS =\< 1
* Effective contraception during study medication and up to 3 months from treatment discontinuation
* Signed informed consent form
Exclusion Criteria:
* Surgical intervention \< 4 weeks
* Pregnancy or lactation
* Known allergic reaction to trabectedin or gemcitabine or one of their components
* The following laboratory values:
Absolute neutrophil count \< 1.5 x 103/mm3 Platelets \< 100.000/mm3 Hb \< 9 g/dL Serum creatinine \>= 2.5 mg/dl SGOT and/or SGPT and/or alkaline phosphatase and/or CPK \> 2.5 x ULN Total bilirubin \> 1 x ULN except in the case of Gilbert's syndrome
* Participation in another study (four weeks before and during the study)
* Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01426633
Study Brief:
Protocol Section:
NCT01426633