A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX (FORTO)

Isofol Medical

Status: Completed

Conditions: Osteosarcoma

Treatments: Drug: Methotrexate

Study type: Observational

Funder types: Industry

Identifiers

NCT02383901

ISO-MTX-OB1

Details and patient eligibility

About

The purpose of this study is to investigate to which extend osteosarcoma patients do NOT meet the criteria for successfully advancement to next planned chemotherapy course.

Full description

Methotrexate is one of the most effective chemotherapy drugs in the treatment of osteosarcoma. However, it has severe side effects. The physicians tries to save or "rescue" normal cells from the side effects of methotrexate by giving folinic acid. Folinic acid administration starts 24 hours after methotrexate and given regularly until methotrexate levels are low and not dangerous to normal cells anymore. Despite this rescue, side effects are still a problem and many patients are not well enough to receive subsequent chemotherapy on time.

This is a multi-center, observational retrospective study with osteosarcoma patients, 2 years of age or older, who have received at least one (1) course of HDMTX treatment with folate rescue in a MAP schedule between 01January 2009 and 31 May 2014, both dates included.

Patients must have initiated their HDMTX treatment after 01 January 2009, received at least one (1) course of HDMTX treatment with folate rescue, and received their last MAP intervention (regardless if the patients received all planned HDMTX treatments or terminated prematurely their treatment) by 31 May 2014.

Patient data collected for the study will be extracted from hospital medical records and will include information related to scheduled and/or received HDMTX courses. The collected data will include: laboratory values confirming suitability to receive next chemotherapy intervention at scheduled time, drug administration regimen (both HDMTX and supportive care), toxicity management (hydration and folate rescue regimens), and toxicity monitoring.

Enrollment: 116 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have histological evidence of osteosarcoma including metastatic osteosarcoma.
• Patients must have initiated their HDMTX treatment after 01 January 2009 and should have completed their MAP treatment by 31 May 2014.
• Patients should have received at least one (1) HDMTX course within MAP treatment.
• Patients must be at least 2 years of age.
• Patient, parent(s), or guardian(s), as appropriate, is/are willing to provide signed informed consent, if applicable according to national regulation.

Exclusion criteria

• No exclusion criteria