Randomized, Open, Multicenter, Prospective, Phase II Clinical Trial of Doxorubicin vs. Trabectedin Plus Doxorubicin in the First Line Treatment of Patients With Advanced Non Operable and/or Metastatic Soft Tissue Sarcomas
- 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)
- Synovial sarcoma
- 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).
- Previous chemotherapy treatment.
- Previous radiotherapy involving the only localization(s) of measurable tumoral
- 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
- 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:
- Ewing's family of tumors
- Desmoplastic small round cell tumor
- Clear cell sarcoma
- Alveolar sarcoma