An Analysis of the Efficacy of High Dose Isofosfamide Through Elastomer

Osteosarcoma Recurrent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651569
• Other study ID #: HD-IFOel
• Status: Completed
• Start date: October 2, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteosarcoma
• Osteosarcoma Recurrent

Intervention

Other:
• Observational study
none, Observational study

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Disease remission or disease progression	Evaluated during the first 4 months at the end of treatment
Primary	growth modulation index - GMI	ratio of time to progression (TTP) with nth line of therapy (TTPn) to the most recent prior line of therapy (TTPn-1)	Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)
Primary	toxicity according to CTCAE v.5.0	Disease evaluation	Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)