high grade relapsed osteosarcoma MedDRA version: 20.0 Level: PT Classification code 10031291 Term: Osteosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: GEMCITABINA ACCORD - 100 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 2 ML
Product Name: Gemcitabina
Product Code: Gemcitabina
Pharmaceutical Form: Concentrate fo
Sponsors
ITALIAN SARCOMA GROUP
Eligibility
Sex/Gender
All
Inclusion 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. 11) Negative pregnancy test for female and effective contraception method for potentially feritile females For fertile female patients is required a contraception methods needs to be taken for all the treatment period. Contraception method for male patients need to taken up to 6 month to the end of treatment 12) Provvision of written Informed Consent Are the trial subjects under 18? yes 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 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy, safety and clinical benefit in patients with relapsed osteosarcoma (OS) treated with High dose ifosfamide or with Gemcitabine+docetaxel;Secondary Objective: none;Primary end point(s): 6 months Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival (OS); Toxicity ; Quality of Life; Hospitalization time ; Rate of post-chemotheray surgical interventions; Overall Response Rate (ORR) Overall ;Timepoint(s) of evaluation of this end point: At time of death; After each cycle; At the end of Chemotheerap; fter each cycle; After 6 cycles; After 6 cycles | — |
Countries
Italy
Contacts
Public ContactClinical Trial Unit
Italian Sarcoma Group
Outcome results
None listed