Clinical trial · Observational
A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX
NCT02383901CI-TRIAL-00023770FORTOcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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.
- timeFrame
- Druing the MAP treatment approx 30 weeks
Secondary outcomes (6)
- measure
- 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.
- timeFrame
- Druing the MAP treatment approx 30 weeks
- measure
- Number of patients with MTX excretion toxicity
- timeFrame
- Druing the MAP treatment approx 30 weeks
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * No exclusion criteria
References
Publications (0)
Data not yet available
No reference posted for this study.