Clinical Trial Of Doxorubicin Versus Trabectedin Plus Doxorubicin In The First Line Treatment Of Patients With Advanced Non Operable And/Or Metastatic Soft Tissue Sarcomas

Inclusion Criteria:

• The patient must sign voluntarily the informed consent from before any study test is conducted that is not part of routine patient care, with the knowledge that he/she can abandon the study at any time without this affecting his/her previous care.
• Aged between 18 and 70.
• Pathological diagnosis of non operable and/or metastatic soft tissue sarcoma.

• The following histological subtypes can be included:

  • Undifferentiated pleomorphic sarcoma (previously,malignant fibrous istiocytoma)
  • Leiomyosarcoma
  • Angiosarcoma
  • Liposarcoma
  • Synovial sarcoma
  • Fibrosarcoma
  • Hemangiopericytoma
  • Neurofibrosarcoma
  • Mixofibrosarcoma
  • Unclassified sarcoma
• Measurable disease, according to RECIST criteria
• Performance status 0-2 Eastern Cooperative Oncology Group(ECOG).
• Adequate bone marrow function (hemoglobin > 10 g/dL, leukocytes ≥ 3.000/mm3, neutrophils ≥1.500/mm3, platelets ≥ 100.000/mm3). Patients with plasma creatinine ≤ 1,6 mg/dL, transaminases ≤2.5 times the upper limit of normal (ULN), total bilirubin ≤ upper limit of normal (ULN), CPK ≤ 2.5 times upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN) are acceptable. If the increase of alkaline phosphatase is > 2.5 times the upper limit of normal (ULN), then the alkaline phosphatase liver fraction and/or 5' nucleotidase and/or GGT must be ≤ upper limit of normal (ULN).
• Men or women of child bearing potential should be using an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative urine pregnancy test before study entry.
• Normal cardiac function with a Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or Multiple Uptake Gated Acquisition Scan (MUGA).

Exclusion Criteria:

• Previous chemotherapy treatment.
• Previous radiotherapy involving the only localization(s) of measurable tumoral disease.
• Performance status> 2 Eastern Cooperative Oncology Group(ECOG).
• Central Nervous System (CNS) metastases.
• Plasma bilirubin > upper limit of normal(ULN).
• Creatinine > 1.6 mg/dL.
• History of other neoplastic disease with the exception of basalioma or in situ cervical cancer adequately treated.
• Significant cardiovascular disease (for example, dyspnea > 2 NYHA)
• Significant systemic diseases grade 3 or higher on the NCI-CTC version 3.0 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.
• Uncontrolled bacterial, mycotic or viral infections.
• Women who are pregnant or breast-feeding
• Psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent.
• Patients participating in another clinical trial or receiving any other investigational product.
• Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.

• The following histologic subtypes are excluded:

  • Rhabdomyosarcoma
  • Ewing's family of tumors
  • Desmoplastic small round cell tumor
  • Clear cell sarcoma
  • Alveolar sarcoma