An Analysis of the Efficacy of High Dose Isofosfamide Through Elastomer

A Multicentre, Retrospective, Observational Study to Analyse the Efficacy of High Dose Isofosfamide Administered Through Elastomer in Patients With Relapsed/ Refractory Osteosarcoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04651569

Enrollment

Registered

2020-12-03

Start date

2020-10-02

Completion date

2022-12-31

Last updated

2023-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteosarcoma Recurrent

Brief summary

A multicentre, observational, retrospective study to analyse the efficacy of high dose isofosfamide thorugh elastomer in patients with relapsed/ refractory osteosarcoma

Interventions

OTHERObservational study

none, Observational study

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)
toxicity according to CTCAE v.5.0	Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)	Disease evaluation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026