An Analysis of the Efficacy of High Dose Isofosfamide Through Elastomer

Completed

• Conditions: Osteosarcoma Recurrent

• Registration Number: NCT04651569
• Lead Sponsor: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

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

Study Timeline

• Study Start: 2020-10-02
• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-03
• Primary Completion: 2021-06-30
• Study Completion: 2022-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-25

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)

Trial Locations

Locations (5)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy

Azienda Ospedaliero Universitaria Meyer; 🇮🇹 Florence, Italy

IRCCS Istituto Nazionale dei Tumori - S.C. Pediatria; 🇮🇹 Milan, Italy

Regina Elena National Cancer Institute IRCCS; 🇮🇹 Roma, Italy

OIRM - AOU Città della Salute e della Scienza di Torino; 🇮🇹 Torino, Italy