Inclusion Criteria

Inclusion Criteria (for the selection part):

- 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)

Exclusion Criteria (for the selection part):

- Patients that have received more than one regimen of chemotherapy for metastatic or
inoperable soft tissue or uterine sarcoma, after the failure/intolerance of
doxorubicin and ifosfamide. Maintenance treatment does not count as treatment line

- The following histological subtypes : GIST, rhabdomyosarcoma, aggressive
fibromatosis, desmoïd tumour, PNET, carcinosarcoma, and all bone sarcomas

- Single tumour in an irradiated region

- Other malignant tumour over the past five years (except basal cell carcinoma or
cervical carcinoma in situ adequately treated)

- Currently active bacterial or fungus infection (> grade 2 CTC [CTCAE] Version 4.02).
Known HIV1, HIV2, hepatitis B or hepatitis C infections

- Presence of known leptomeningeal or brain metastasis

- Patients unable to receive corticotherapy

- Any circumstance that could jeopardise compliance or proper follow-up during the
trial

- Pregnant or nursing women

Inclusion Criteria (for the randomized part):

- 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)

Exclusion Criteria (for the randomized part):

- Tumour progression (according to RECIST 1.1) during the first six Yondelis cycles

- Non-availability of baseline scans prior to the first cycle and following the sixth
cycle

- Currently active bacterial or fungus infection (> grade 2 CTC [CTCAE] Version 4.02).
Known HIV1, HIV2, hepatitis B or hepatitis C infections

- Presence of known leptomeningeal or brain metastasis

- Creatinine clearance less than 30 ml/min

- Patients unable to receive corticotherapy

- Any circumstance that could jeopardise compliance or proper follow-up during the
trial

- Pregnant or nursing women

- Hypersensitivity to Trabectedin or any excipient in prior cycles