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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01758666

Enrollment

Registered

2013-01-01

Start date

2012-09-30

Completion date

2016-12-31

Last updated

2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteosarcoma

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.

Interventions

DRUGMethotrexate,Calcium folinate

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
blood concentration of MTX	up to 3 years

Secondary

Measure	Time frame
other adverse reaction	up to 3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026