A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy

Not Applicable

• Conditions: Osteosarcoma
• Interventions: Drug: Methotrexate,Calcium folinate

• Registration Number: NCT01758666
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-30
• Study Start: 2012-09
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-31
• Study First Posted: 2013-01-01
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-22
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Proved by pathology in 60 cases of osteosarcoma patients
2. PS ≤ 2, survival period is more than 6 months
3. Normal function of liver and kidney
4. No chemotherapy contraindication, patients treat with high dose methotrexate
5. Get signed written informed consent form
6. Have a good compliance with take blood and follow-up

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Methotrexate and Calcium folinate	Methotrexate,Calcium folinate	-

Primary Outcome Measures

Name	Time	Method
blood concentration of MTX	up to 3 years

Secondary Outcome Measures

Name	Time	Method
other adverse reaction	up to 3 years