Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma (NCT01303094) | Clinical Trial Compass
CompletedPhase 2
Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma
France53 participantsStarted 2011-02
Plain-language summary
This randomization discontinuation trial will allow for concomitant evaluation of the following:
* Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle
* Side effects and benefits of a drug holiday
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Oth…