Osteosarcoma RecurrentNCT04651179
Study of Effectiveness of GEMDOX in Relapsed Osteosarcoma
An observational study of Osteosarcoma Recurrent and Osteosarcoma Metastatic, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna at 8 sites in Italy.
Trial summary
A retrospective observational study of the effectiveness of gemcitabine - docetaxel in patients with relapsed osteosarcoma who have been treated with HD IFO in first line treatment Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Osteosarcoma Recurrent, Osteosarcoma Metastatic
- What is being tested?
- observation
- How many people
- 33 participants
- Where
- 8 sitesItaly
- Study dates
- 24 Apr 2020to 23 Nov 2021
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with relapsed osteosarcoma treated with gemcitabine- docetaxel after a first line with HD- IFO
Who may be able to join
- Age at diagnosis of high grade osteosarcoma >= 4
- Received first line treatment with HD IFO
- Following HD IFO treatment, they have been diagnosed refractory disease and they satisfy at least one of the following criteria :
- Relapsed in the first 24 month following the initial diagnosis, regardless of location and resectability
- Lung relapsed disease with more than 2 nodules diagnosed over 24 months from the initial diagnosis
- Non resectable relapsed disease diagnosed over 24 months from the initial diagnosis Before or during GEMDOX treatment, eligible patients may have been subject to metastasectomy
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Istituto Ortopedico Rizzoli
Bologna, 40136
Fondazione del Piemonte per l' Oncologia IRCCS Candiolo
Candiolo, Turin, 10060
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence, 50134
Istituto Nazionale Tumori
Milan, Milano, 20133
IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Azienda Ospedaliero Universitaria pisana
Pisa
IRCCS Istituti Fisioterapici Ospitalieri
Rome, 00144
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
Turin, 10126
About this study
Official title: A Retrospective Observational Study of the Effectiveness of Gemcitabine -Docetaxel in Patients With Relapsed Osteosarcoma Who Have Been Treated With HD-IFO in First Line Treatment
A retrospective observational study of the effectiveness of gemcitabine - docetaxel in patients with relapsed osteosarcoma who have been treated with HD IFO in first line treatment
- Conditions
- Osteosarcoma Recurrent, Osteosarcoma Metastatic
- Being tested
- observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
not applicable, observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to Gemcitabina - Docetaxel Treatment
assessed as overall survival (12 months)
Measured: 12 months
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 start24 Apr 2020
- Primary completion6 Jun 2021
- Study completion23 Nov 2021
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 33 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
- Franca Fagioli, MD, Principal investigator, AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651179
- Sponsor's protocol ID
- OSTEOREC/OSS
- Status last verified
- Nov 2021
- First submitted
- 24 Nov 2020
- Last updated
- 26 Nov 2021
- 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 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Study of the Effectiveness of Gemcitabine -Docetaxel in Patients With Relapsed Osteosarcoma Who Have Been Treated With HD-IFO in First Line Treatment
- ClinicalTrials.gov ID
- NCT04651179
- Acronym / sponsor ID
- OSTEOREC/OSS
- Conditions
- Osteosarcoma Recurrent, Osteosarcoma Metastatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaUniversity, hospital or other
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 23 Nov 2021 (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 retrospective observational study of the effectiveness of gemcitabine - docetaxel in patients with relapsed osteosarcoma who have been treated with HD IFO in first line treatment
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with relapsed osteosarcoma treated with gemcitabine- docetaxel after a first line with HD- IFO
Key inclusion criteria (6 listed)
- Age at diagnosis of high grade osteosarcoma >= 4
- Received first line treatment with HD IFO
- Following HD IFO treatment, they have been diagnosed refractory disease and they satisfy at least one of the following criteria :
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| observationnot applicable, observational study | Other | – |
Primary outcome
Response to Gemcitabina - Docetaxel Treatment
Time frame: 12 months
assessed as overall survival (12 months)
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 26 Nov 2021.
- 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.
Franca Fagioli, MD principal investigator
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
8 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 and Osteosarcoma Metastatic, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna at 8 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 6 inclusion and 0 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 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Response to Gemcitabina - Docetaxel Treatment (time frame: 12 months). 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 26 Nov 2021.