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

Tianjin Medical University

Status: Unknown

Conditions: Osteosarcoma

Treatments: Drug: Methotrexate,Calcium folinate

Study type: Interventional

Funder types: Other

Identifiers

NCT01758666

CIH-WAC-201205001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Methotrexate and Calcium folinate

Experimental group

Treatment:

Drug: Methotrexate,Calcium folinate