Trabectedin First Line Therapy In Unfit Sarcoma Study

Inclusion criteria

* Adult patients (≥18 years), who, in the judgment of the clinician, is deemed not suitable to receive an anthracycline and/or ifosfamide based chemotherapy;
* Pathological diagnosis of soft tissue sarcoma
* Inoperable, locally advanced or metastatic tumor;
* Unsuited to receive doxorubicine and ifosfamide: ie stable arrhythmia, previous myocardial infarction; age≥80 years
* Eastern Cooperative Oncology Group Performance Status 0-2
* Glomerular filtration rate ≥30 mL per min
* Adequate hematologic function: Hemoglobin ≥9 g/dL; Absolute neutrophil count ≥1,500/μL, and Platelet count ≥100,000/microliter
* Creatinine phosphokinase \< 2.5 Upper Normal Limit
* Adequate hepatic function: total bilirubin \< Upper Normal Limit, total alkaline phosphatase \< 2.5 Upper Normal Limit, or if \> 2.5 Upper Normal Limit consider alkaline phosphatase liver fraction or gamma-glutamyltransferase or 5' nucleotidase must be \< Transminase \<2.5 x Upper Normal Limit, Albumin \> 20 g/L.
* Patient´s written informed consent

Exclusion criteria

* Prior exposure to Trabectedin
* Performance status ≥2.
* Prior treatment with anthracyclines and or ifosfamide.
* History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 or more years and judged of negligible potential of relapse.
* Active viral hepatitis or chronic liver diseases, which in the judgement of the primary investigator represents a clinical contraindication to the therapy.
* Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 6 months before enrolment, uncontrolled arterial hypertension or arrhythmias, left ventricular ejection fraction \<40%
* Active major infection.
* Other serious concomitant illnesses
* Pregnant subjects or breast feeding, or planning to become pregnant within 6 months after the end of treatment All sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrollment and must agree to use highly effective contraception during treatment and for 6 months after the end of treatment.