An Analysis of the Efficacy of High Dose Isofosfamide Through Elastomer
Completed
- Conditions
- Osteosarcoma Recurrent
- Registration Number
- NCT04651569
- Brief Summary
A multicentre, observational, retrospective study to analyse the efficacy of high dose isofosfamide thorugh elastomer in patients with relapsed/ refractory osteosarcoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- Diagnosis of high risk relapsed/ refractory osteosarcoma
- Aged <= 40 years at the beginning of treatment
- at least one completed cycle of HD IFO through elastomer (14g/mq) in 14 days
- disease evaluation according to RECIST criteria v.1.1
Exclusion Criteria
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method toxicity according to CTCAE v.5.0 Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI) Disease evaluation
Progression Free Survival Evaluated during the first 4 months at the end of treatment Disease remission or disease progression
growth modulation index - GMI Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI) ratio of time to progression (TTP) with nth line of therapy (TTPn) to the most recent prior line of therapy (TTPn-1)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
OIRM - AOU Citt脿 della Salute e della Scienza di Torino
馃嚠馃嚬Torino, Italy
Istituto Ortopedico Rizzoli
馃嚠馃嚬Bologna, Italy
Azienda Ospedaliero Universitaria Meyer
馃嚠馃嚬Florence, Italy
Regina Elena National Cancer Institute IRCCS
馃嚠馃嚬Roma, Italy
IRCCS Istituto Nazionale dei Tumori - S.C. Pediatria
馃嚠馃嚬Milan, Italy