Back to resultsA Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy
Primary Purpose
Osteosarcoma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Methotrexate,Calcium folinate
Sponsored by
About this trial
This is an interventional treatment trial for Osteosarcoma
Eligibility Criteria
Inclusion Criteria:
- Proved by pathology in 60 cases of osteosarcoma patients
- PS ≤ 2, survival period is more than 6 months
- Normal function of liver and kidney
- No chemotherapy contraindication, patients treat with high dose methotrexate
- Get signed written informed consent form
- Have a good compliance with take blood and follow-up
Exclusion Criteria:
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Methotrexate and Calcium folinate
Arm Description
Outcomes
Primary Outcome Measures
blood concentration of MTX
Secondary Outcome Measures
other adverse reaction
Full Information
NCT ID
NCT01758666
First Posted
August 30, 2012
Last Updated
December 21, 2015
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01758666
Brief Title
A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Methotrexate and Calcium folinate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methotrexate,Calcium folinate
Primary Outcome Measure Information:
Title
blood concentration of MTX
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
other adverse reaction
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Proved by pathology in 60 cases of osteosarcoma patients
PS ≤ 2, survival period is more than 6 months
Normal function of liver and kidney
No chemotherapy contraindication, patients treat with high dose methotrexate
Get signed written informed consent form
Have a good compliance with take blood and follow-up
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Wang
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy
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