A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy
|ClinicalTrials.gov Identifier: NCT01758666|
Recruitment Status : Unknown
Verified December 2012 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was: Active, not recruiting
First Posted : January 1, 2013
Last Update Posted : December 22, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteosarcoma||Drug: Methotrexate,Calcium folinate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2016|
U.S. FDA Resources
|Experimental: Methotrexate and Calcium folinate||Drug: Methotrexate,Calcium folinate|
- blood concentration of MTX [ Time Frame: up to 3 years ]
- other adverse reaction [ Time Frame: up to 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758666
|Study Chair:||Chen Wang||Tianjin Medical University Cancer Institute and Hospital|