An Analysis of the Efficacy of High Dose Isofosfamide Through Elastomer

May 24, 2023 updated by: Prof. Franca Fagioli, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli
      • Florence, Italy, 50139
        • Azienda Ospedaliero Universitaria Meyer
      • Milan, Italy, 20133
        • IRCCS Istituto Nazionale dei Tumori - S.C. Pediatria
      • Roma, Italy, 00144
        • Regina Elena National Cancer Institute IRCCS
      • Torino, Italy, 10126
        • OIRM - AOU Città della Salute e della Scienza di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with relapsed/ refractory osteosarcom

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Evaluated during the first 4 months at the end of treatment
Disease remission or disease progression
Evaluated during the first 4 months at the end of treatment
growth modulation index - GMI
Time Frame: 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)
Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)
toxicity according to CTCAE v.5.0
Time Frame: Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)
Disease evaluation
Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Investigators

  • Study Chair: Celeste Cagnazzo, PhD, AOU Citta della Salute e della Scienza di Torino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

November 25, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-IFOel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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