A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy
At present, the most effective drugs to osteosarcoma include ADM,DDP,,HD-MTX,IFO and so on.The effective rate of single drug was about 30%, and if the chemotherapy contains HD-MTX, the survival rate can reach about 60%, so the HD-MTX is the most important component in patients of osteosarcoma.
Studies have shown that, MTX efficacy and adverse reactions were associated with blood concentration level and duration, selecting the right time and dose to give CF is the critical point.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- blood concentration of MTX [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
- other adverse reaction [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
|Experimental: Methotrexate and Calcium folinate||Drug: Methotrexate,Calcium folinate|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758666
|Study Chair:||Chen Wang||Tianjin Medical University Cancer Institute and Hospital|