Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
High Dose Methotrexate (HDMTX) is an integral part of osteosarcoma therapy whose main
toxicities include myelosuppression, mucositis, nephrotoxicity, and hepatitis. In order to
deliver HDMTX therapy safely, patients require urinary alkalinization, hydration, monitoring
of renal function, therapeutic drug monitoring, and leucovorin rescue. Due to the required
supportive care needs, HDMTX has historically been given as an inpatient. In some centers
however, HDMTX is being given safely as an outpatient in order to reduce health care costs,
improve patient quality of life and to deliver timely therapy with limited inpatient
chemotherapy beds available.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The proportion of outpatient High Dose Methotrexate courses which result in an inpatient hospital admission.
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.
Eleanor Hendershot, MN NP-Peds
The Hospital for Sick Children, Toronto Canada
Canada: Health Canada