EUCTR2007-000035-25-IT
Active, Not Recruiting
N/A
A multicenter Phase II clinical trial of neoadjuvant trabectedin (Yondelis) in patients with localized myxoid / round cell liposarcoma. - ND
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- ocalized myxoid / round cell liposarcoma (MRCL).
- Sponsor
- PHARMA MAR
- Enrollment
- 22
- Status
- Active, Not Recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •PatientŽs written informed consent before any study\-specific procedure Adult patients (more than or equal to 18 years)
- •Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of pathology specimens for central review and pharmacogenomic studies
- •Clinical evidence of localized, non\-metastatic tumor, including locally recurring disease after initial surgery
- •Measurable disease (by RECIST)
- •No prior chemotherapy or radiation (except for adjuvant post\-operative radiotherapy)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0\-2
- •Hematologic variables:
- •oHemoglobin more than or equal to 9 g/dL
- •oAbsolute neutrophil count (ANC)more than or equal to 1,500/µL, and oPlatelet count more than or equal to 100,000/µL
- •Serum creatinine less than or equal to 1\.5 mg/dL or creatinine clearance more than or equal to 30 mL/min
Exclusion Criteria
- •Known hypersensitivity to any of the components of the trabectedin i.v. formulation or dexamethasone
- •Pregnant or lactating women or any patient of childbearing potential who are not employing adequate contraception
- •History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer
- •Known distant metastases
- •Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias
- •Psychiatric disorder that prevents compliance with protocol
- •Active viral hepatitis or chronic liver disease
- •Active infection
- •Any other unstable medical condition
Outcomes
Primary Outcomes
Not specified
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