Clinical trial · Interventional
Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
NCT01176981CI-TRIAL-00054733completedPhase 3Results postedClinicalTrials.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 primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.
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 |
|---|---|---|---|
| High Dose Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HDMTX
- description
- This is a single arm study. All subjects enrolled in the study will be in this arm.
- interventionNames
- Drug: High Dose Methotrexate
Primary outcomes (1)
- measure
- The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission.
- timeFrame
- 9 months
- description
- Patients will be evaluated prior to and daily during each outpatient HDMTX course, and if one or more of a list of hospitalization criteria are met, the patient will be admitted to hospital to complete that course.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 6 years of age; * Localized or metastatic osteosarcoma; * Adequate renal function (GFR \> 70 ml/1.73m2) prior to each cycle; * No grade III/IV renal toxicity, mucositis or vomiting with most recent prior inpatient MTX cycle; * Parent and/or patient must be able to provide written consent, and complete Patient Flow Sheets in English. Exclusion Criteria: * Patients, in the opinion of the primary healthcare team, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal. * Pregnant females * Breastfeeding females
References
Publications (0)
Data not yet available
No reference posted for this study.