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

Osteosarcoma Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01758666
• Other study ID #: CIH-WAC-201205001
• Status: Active, not recruiting
• Phase: N/A
• First received: August 30, 2012
• Last updated: December 21, 2015
• Start date: September 2012
• Est. completion date: December 2016

Study information

• Verified date: December 2012
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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:

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• Methotrexate,Calcium folinate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood concentration of MTX		up to 3 years	Yes
Secondary	other adverse reaction		up to 3 years	Yes