- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04651569
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
-
-
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Bologna, Italy, 40136
- Istituto Ortopedico Rizzoli
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Florence, Italy, 50139
- Azienda Ospedaliero Universitaria Meyer
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Milan, Italy, 20133
- IRCCS Istituto Nazionale dei Tumori - S.C. Pediatria
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Roma, Italy, 00144
- Regina Elena National Cancer Institute IRCCS
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Torino, Italy, 10126
- OIRM - AOU Città della Salute e della Scienza di Torino
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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.
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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