ON PEGILATED LIPOSOMIAL DOXORUBICIN (TLC D-99) IN ASSOCIATION WITH IFOSFAMIDE IN PATIENTS WITH METASTATIC SOFT TISSUE SARCOMA - ND
- Conditions
- METASTATIC SOFT TISSUE SARCOMASMedDRA version: 9.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomas
- Registration Number
- EUCTR2008-003316-36-IT
- Lead Sponsor
- CENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- CONFIRMED DIAGNOSIS OF METASTATIC SOFT TISSUE SARCOMA OR RELAPSED AFTER 6 MONTHS OF ADJUVANT OR NEOADJUVANT CHEMOTEHRAPY - AGE > 18 YEARS - PS 3 MONTHS
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- PREVIOUS CHEMOTHERAPY WITH CUMULATIVE DOSE OF ADRIAMYCINE >/= 300 MG/M² OR EPIRUBICINE > 600 MG/M² - PREGNANCY OR LACTANCY - UNCONTROLLED CONCOMITANT DISEASES OR INFECTIONS - CLINICAL SIGNS OF BRAIN METASTASES
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: DETERMINING GLOBAL RESPONSE RATE AND CLINICAL BENEFIT IN PATIENTS WITH METASTATIC SOFT TISSUE SARCOMAS.;Secondary Objective: DETERMINING TIME TO PROGRESSION, DURATION OF RESPONSE, INDUCED TOXICITY AND OVERALL SURVIVAL;Primary end point(s): RESPONSE TO TREATMENT
- Secondary Outcome Measures
Name Time Method