CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6 enrolled
Drug / intervention
High Dose Methotrexatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01176981
NCT01176981Phase 3Completed
CompareCT.gov

Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma

The Hospital for Sick Children·interventional·Posted Aug 6, 2010·Updated Oct 28, 2021

In Brief

A Phase 3 clinical trial evaluating High Dose Methotrexate for Osteosarcoma. Completed, enrolled 6 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteosarcoma
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2010
Enrollment StartOct 1, 2010
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.9 years ago

Interventions

High Dose Methotrexatedrug

Methotrexate will be given by IV at a dose of 12 gram/m2/dose. The patient will receive 4-6 hours of hydration with alkalinization, and then HD MTX will be infused over 4 hours. Following this, the patient will be discharged home to receive continuous intravenous hydration through a portable pump. The patient will return to hospital daily for a comprehensive clinical assessment, IV hydration and antiemetics, MTX level and creatinine monitoring until MTX is cleared (3-4 days).