This trial is active, not recruiting.

Condition osteosarcoma
Treatment methotrexate,calcium folinate
Sponsor Tianjin Medical University Cancer Institute and Hospital
Start date September 2012
End date November 2016
Trial size 40 participants
Trial identifier NCT01758666, CIH-WAC-201205001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
methotrexate,calcium folinate

Primary Outcomes

blood concentration of MTX
time frame: up to 3 years

Secondary Outcomes

other adverse reaction
time frame: up to 3 years

Eligibility Criteria

Male or female participants from 12 years up to 60 years old.

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 information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Tianjin Medical University Cancer Institute and Hospital.