Osteosarcoma RecurrentNCT04651569
An Analysis of the Efficacy of High Dose Isofosfamide Through Elastomer
An observational study of Osteosarcoma Recurrent, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna at 5 sites in Italy.
Trial summary
A multicentre, observational, retrospective study to analyse the efficacy of high dose isofosfamide thorugh elastomer in patients with relapsed/ refractory osteosarcoma Read more about this study
- Who is it for?
- Ages Up to 40 years
- Conditions the study is for
- Osteosarcoma Recurrent
- What is being tested?
- Observational study
- How many people
- 26 participants
- Where
- 5 sitesItaly
- Study dates
- 2 Oct 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients with relapsed/ refractory osteosarcom
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Istituto Ortopedico Rizzoli
Bologna, 40136
Azienda Ospedaliero Universitaria Meyer
Florence, 50139
IRCCS Istituto Nazionale dei Tumori - S.C. Pediatria
Milan, 20133
Regina Elena National Cancer Institute IRCCS
Roma, 00144
OIRM - AOU Città della Salute e della Scienza di Torino
Torino, 10126
About this study
Official title: 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
- Conditions
- Osteosarcoma Recurrent
- Being tested
- Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
none, Observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Disease remission or disease progression
Measured: Evaluated during the first 4 months at the end of treatment
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)
Measured: Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)
toxicity according to CTCAE v.5.0
Disease evaluation
Measured: Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start2 Oct 2020
- Primary completion30 Jun 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteosarcoma RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Franca Fagioli, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
- Investigators
- Celeste Cagnazzo, PhD, Study chair, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651569
- Sponsor's protocol ID
- HD-IFOel
- Status last verified
- May 2023
- First submitted
- 25 Nov 2020
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Retrospective, Observational Study to Analyse the Efficacy of High Dose Isofosfamide Administered Through Elastomer in Patients With Relapsed/ Refractory Osteosarcoma
- ClinicalTrials.gov ID
- NCT04651569
- Acronym / sponsor ID
- HD-IFOel
- Conditions
- Osteosarcoma Recurrent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicentre, observational, retrospective study to analyse the efficacy of high dose isofosfamide thorugh elastomer in patients with relapsed/ refractory osteosarcoma
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients with relapsed/ refractory osteosarcom
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studynone, Observational study | Other | – |
Primary outcome
Progression Free Survival
Time frame: Evaluated during the first 4 months at the end of treatment
Disease remission or disease progression
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)
toxicity according to CTCAE v.5.0
Time frame: Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)
Disease evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celeste Cagnazzo, PhD study chair
A.O.U. Città della Salute e della Scienza
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma Recurrent, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Evaluated during the first 4 months at the end of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.