Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma

Inclusion Criteria

• •Inoperable or metastatic soft tissue sarcoma and/or uterine sarcoma
• •Measurable lesions (RECIST 1.1)
• •Performance status ≤ 2
• •Age ≥ 18
• •Normal hematological parameters (polynuclear neutrophils ≥ 1500, hemoglobin level ≥ 9 g/dl, platelets counts ≥ 100,000)
• •Adequate biological parameters :
• •Adequate hepatic function (bilirubin ≤ ULN , SGPT/ALT and SGOT/AST ≤ 2.5 x ULN)
• •Alkaline phosphatases ≤ 2.5 x ULN, If Alkaline phosphatases ≥ 2.5 ULN, hepatic isoenzymes 5-nucleotidases or GGT tests must be performed; hepatic isoenzymes 5- nucleotidases and/or GGT must be within the normal range
• •Albumin ≥ 25 g/L
• •Adequate renal function : Serum creatinine ≤ 1.5 x ULN
• •Creatine phosphokinase ≤ 2.5 x ULN
• •Adequate central venous access
• •Pregnant or lactating women or men of reproductive potential must use effective contraceptive methods
• •Patient covered by government health insurance
• •Information sheet given to the patient (Patient information sheet 1)
• •Patient registered in the selection part
• •Stable tumour or objective response (CR + PR) after 6 Trabectedin (Yondelis®) cycles, according to local assessment
• •Available copies of thoraco-abdominal and pelvic scan performed prior to the first cycle and after the sixth cycle
• •Performance status ≤ 2
• •Patients receiving at least 1 mg/m²/3 weeks of Trabectedin at the time of the sixth cycle
• •Normal hematological parameters (polynuclear neutrophils ≥ 1500, hemoglobin level ≥ 9 g/dl, platelets counts ≥ 100,000)
• •Adequate biological parameters :
• •Adequate hepatic function (bilirubin ≤ ULN , SGPT/ALT and SGOT/AST ≤ 2.5 x ULN)
• •Alkaline phosphatases ≤ 2.5 x ULN, If Alkaline phosphatases ≥ 2.5 ULN, hepatic isoenzymes 5-nucleotidases or GGT tests must be performed; hepatic isoenzymes 5- nucleotidases and/or GGT must be within the normal range
• •Albumin ≥ 25 g/L
• •Adequate renal function : Serum creatinine ≤ 1.5 x ULN
• •Creatine phosphokinase (CPK) ≤ 2.5 x ULN
• •Adequate central venous access
• •Pregnant or lactating women or men of reproductive potential must use effective contraceptive methods
• •Informed consent form signed by the patient or the patient's legal representative (patient information sheet 2 and informed consent)