EUCTR2015-004762-28-IT
Active, not recruiting
Phase 1
Multicentric prospective, randomized, clinical trial for the treatment of patient with relapsed Osteosarcoma (OS) - OsteoREC2015
DrugsGEMCITABINA ACCORD - 100 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 2 MLDOCETAXEL HAMELN RDS - 20 MG/0.5 ML CONCENTRATO E SOLVENTE PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO CONCENTRATO 20 MG/0.5 ML+1 FLACONCINO IN VETRO SOLVENTE 1.5 MLHOLOXAN - 1 G POLVERE PER SOLUZIONE INIETTABILE 1 FLACONCINO
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITALIAN SARCOMA GROUP
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)High grade relapsed OS
- •2\)Relapsed disease within 24months form the inital diagnosis
- •3\) Plural\-lung relapse with more than 2 nodules
- •4\) First releapsed disease (regardless the site) not amenable for surgery
- •5\) Second relapse regardless the site and resecability
- •6\) Age \= 4 yrs
- •7\)Lansky score o Karnofsky Performance status \>60%
- •8\) Notrmal for age kidney and liver functionality
- •9\) LVEF \> 50%.
- •10\) WBC 3 x 109/L, plateelets \>100 x 109/l.
Exclusion Criteria
- •1\) Clincal controindications to the use of IMPs.
- •2\) Social, psycological and geographical condition that could comprimise/jeopadize the study.
- •3\) Active HIV, HBV e HCV infection
- •4\) Pregnancy or breast feeding
- •5\) Previous treatment with Gem\-Dox and/or HD\-IFO).
Outcomes
Primary Outcomes
Not specified
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