Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT01303094
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01303094
Study Brief:
Protocol Section:
NCT01303094