Phase 3 N=6 Treatment

Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma

Osteosarcoma

Bottom Line

View on ClinicalTrials.gov: NCT01176981 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission. — 0 courses of MTX

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: High Dose Methotrexate (Drug)
Age: Pediatric, Adult · 6+ yrs
Sex: All
Sponsor: The Hospital for Sick Children
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission.	—	—

Summary

The primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.

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

View full record on ClinicalTrials.gov →

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.