Osteosarcoma Clinical Trial
Official title:
A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX
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.
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.
;
Observational Model: Cohort, Time Perspective: Retrospective
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