OsteosarcomaFORTONCT02383901
A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX
An observational study of Osteosarcoma, run by Isofol Medical AB at 5 sites in 4 countries.
Trial summary
The purpose of this study is to investigate to which extend osteosarcoma patients do NOT meet the criteria for successfully advancement to next planned chemotherapy course. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Methotrexate
- How many people
- 116 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Sep 2014to May 2016
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Osteosarcoma patients, 2 years of age or older. Patients must have received at least one course of HDMTX treatment with folate rescue in a MAP schedule. The treatment must have been initiated by 01 January 2009 and completed by 31 May, 2014
Who may be able to join
- Patients must have histological evidence of osteosarcoma including metastatic osteosarcoma.
- Patients must have initiated their HDMTX treatment after 01 January 2009 and should have completed their MAP treatment by 31 May 2014.
- Patients should have received at least one (1) HDMTX course within MAP treatment.
- Patients must be at least 2 years of age.
- Patient, parent(s), or guardian(s), as appropriate, is/are willing to provide signed informed consent, if applicable according to national regulation.
Who cannot join
- No exclusion criteria
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Sweden2 sites
Skåne University Hospital
Lund, 221 85
Karolinska University Hospital, Sweden
Stockholm, SE-17176
Poland1 site
Intytut Matki Dziecka Klinika Chirurgii Onkologicznej Dzieci i Młodzieży
Warsaw, 01 211
About this study
The purpose of this study is to investigate to which extend osteosarcoma patients do NOT meet the criteria for successfully advancement to next planned chemotherapy course.
Read the detailed description
Methotrexate is one of the most effective chemotherapy drugs in the treatment of osteosarcoma. However, it has severe side effects. The physicians tries to save or "rescue" normal cells from the side effects of methotrexate by giving folinic acid. Folinic acid administration starts 24 hours after methotrexate and given regularly until methotrexate levels are low and not dangerous to normal cells anymore. Despite this rescue, side effects are still a problem and many patients are not well enough to receive subsequent chemotherapy on time.
This is a multi-center, observational retrospective study with osteosarcoma patients, 2 years of age or older, who have received at least one (1) course of HDMTX treatment with folate rescue in a MAP schedule between 01January 2009 and 31 May 2014, both dates included.
Patients must have initiated their HDMTX treatment after 01 January 2009, received at least one (1) course of HDMTX treatment with folate rescue, and received their last MAP intervention (regardless if the patients received all planned HDMTX treatments or terminated prematurely their treatment) by 31 May 2014.
Patient data collected for the study will be extracted from hospital medical records and will include information related to scheduled and/or received HDMTX courses. The collected data will include: laboratory values confirming suitability to receive next chemotherapy intervention at scheduled time, drug administration regimen (both HDMTX and supportive care), toxicity management (hydration and folate rescue regimens), and toxicity monitoring.
- Conditions
- Osteosarcoma
- Being tested
- Methotrexate
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
The study includes osteosarcoma patients who have received MAP treatment, MAP treatment contains 12 courses of Methotrexate
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients classified as NOT having met the criteria for successful advancement from the first to second HDMTX course within the same MAP and/or next MAP cycle at scheduled time in any given HDMTX courses.
Measured: Druing the MAP treatment approx 30 weeks
Secondary outcomes (6)
Administrated HDMTX courses classified as NOT having met the criteria for successful advancement from first to second HDMTX course and/or from the second HDMTX course to the next MAP cycle at scheduled time.
Measured: Druing the MAP treatment approx 30 weeks
Number of patients with MTX excretion toxicity
Measured: Druing the MAP treatment approx 30 weeks
AEs and laboratory test values that resulted in change of folate management reported during the MAP cycle that led or contributed to NOT successfully advancement to next treatment at scheduled time.
Measured: Druing the MAP treatment approx 30 weeks
AEs and laboratory test values reported during the MAP cycle that led or contributed to changes in planned hydration strategy.
Measured: Druing the MAP treatment approx 30 weeks
AEs and laboratory test values reported during the MAP cycle that led or contributed to changes in planned folate rescue strategy.
Measured: Druing the MAP treatment approx 30 weeks
Characterization of the S-MTX elimination profile and management
Measured: Druing the MAP treatment approx 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isofol Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikael Eriksson, MD PhD., Principal investigator, Skåne Universitiy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383901
- Sponsor's protocol ID
- ISO-MTX-OB1
- Acronym
- FORTO
- Status last verified
- Sep 2016
- First submitted
- 29 Oct 2014
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publication in relevant forum planned after finalization of study report
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX
- ClinicalTrials.gov ID
- NCT02383901
- Acronym / sponsor ID
- FORTO / ISO-MTX-OB1
- Conditions
- Osteosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Isofol Medical ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Mar 2015 (estimated)
- 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.
The purpose of this study is to investigate to which extend osteosarcoma patients do NOT meet the criteria for successfully advancement to next planned chemotherapy course.
Detailed description
Methotrexate is one of the most effective chemotherapy drugs in the treatment of osteosarcoma. However, it has severe side effects. The physicians tries to save or "rescue" normal cells from the side effects of methotrexate by giving folinic acid. Folinic acid administration starts 24 hours after methotrexate and given regularly until methotrexate levels are low and not dangerous to normal cells anymore. Despite this rescue, side effects are still a problem and many patients are not well enough to receive subsequent chemotherapy on time.
This is a multi-center, observational retrospective study with osteosarcoma patients, 2 years of age or older, who have received at least one (1) course of HDMTX treatment with folate rescue in a MAP schedule between 01January 2009 and 31 May 2014, both dates included.
Patients must have initiated their HDMTX treatment after 01 January 2009, received at least one (1) course of HDMTX treatment with folate rescue, and received their last MAP intervention (regardless if the patients received all planned HDMTX treatments or terminated prematurely their treatment) by 31 May 2014.
Patient data collected for the study will be extracted from hospital medical records and will include information related to scheduled and/or received HDMTX courses. The collected data will include: laboratory values confirming suitability to receive next chemotherapy intervention at scheduled time, drug administration regimen (both HDMTX and supportive care), toxicity management (hydration and folate rescue regimens), and toxicity monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Osteosarcoma patients, 2 years of age or older. Patients must have received at least one course of HDMTX treatment with folate rescue in a MAP schedule. The treatment must have been initiated by 01 January 2009 and completed by 31 May, 2014
Key inclusion criteria (5 listed)
- Patients must have histological evidence of osteosarcoma including metastatic osteosarcoma.
- Patients must have initiated their HDMTX treatment after 01 January 2009 and should have completed their MAP treatment by 31 May 2014.
- Patients should have received at least one (1) HDMTX course within MAP treatment.
- Patients must be at least 2 years of age.
- Patient, parent(s), or guardian(s), as appropriate, is/are willing to provide signed informed consent, if applicable according to national regulation.
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| MethotrexateThe study includes osteosarcoma patients who have received MAP treatment, MAP treatment contains 12 courses of Methotrexate | Drug | – |
Primary outcome
Proportion of patients classified as NOT having met the criteria for successful advancement from the first to second HDMTX course within the same MAP and/or next MAP cycle at scheduled time in any given HDMTX courses.
Time frame: Druing the MAP treatment approx 30 weeks
6 secondary outcomes
Administrated HDMTX courses classified as NOT having met the criteria for successful advancement from first to second HDMTX course and/or from the second HDMTX course to the next MAP cycle at scheduled time.
Time frame: Druing the MAP treatment approx 30 weeks
Number of patients with MTX excretion toxicity
Time frame: Druing the MAP treatment approx 30 weeks
AEs and laboratory test values that resulted in change of folate management reported during the MAP cycle that led or contributed to NOT successfully advancement to next treatment at scheduled time.
Time frame: Druing the MAP treatment approx 30 weeks
AEs and laboratory test values reported during the MAP cycle that led or contributed to changes in planned hydration strategy.
Time frame: Druing the MAP treatment approx 30 weeks
AEs and laboratory test values reported during the MAP cycle that led or contributed to changes in planned folate rescue strategy.
Time frame: Druing the MAP treatment approx 30 weeks
Characterization of the S-MTX elimination profile and management
Time frame: Druing the MAP treatment approx 30 weeks
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 5 Sep 2016.
- Individual participant dataSharing planned: Yes. Publication in relevant forum planned after finalization of study report
Related trials for Osteosarcoma
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The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
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RecruitingPhase 2
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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.
Mikael Eriksson, MD PhD. principal investigator
Skåne Universitiy Hospital
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma, run by Isofol Medical AB at 5 sites in 4 countries.
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 5 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 5 Sep 2016. 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 Sweden, Hungary, Norway, Poland. 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?
Proportion of patients classified as NOT having met the criteria for successful advancement from the first to second HDMTX course within the same MAP and/or next MAP cycle at scheduled time in any given HDMTX courses. (time frame: Druing the MAP treatment approx 30 weeks). 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 5 Sep 2016.