Phase 3
Completed N=6
Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Source: ClinicalTrials.gov NCT01176981 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission. — 0 courses of MTX
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission. |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01176981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.