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

Tianjin Medical University Cancer Institute and Hospital40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteosarcoma

Interventions

Methotrexate,Calcium folinate

Eligibility

Sex: ALLMin age: 12 YearsMax age: 60 Years

Medical Language ↔ Plain English

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:

Outcomes

Primary Outcomes

blood concentration of MTX

Time frame: up to 3 years

Secondary Outcomes

other adverse reaction

Time frame: up to 3 years