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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01758666
First Posted: January 1, 2013
Last Update Posted: December 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
August 30, 2012
January 1, 2013
December 22, 2015
September 2012
November 2016   (Final data collection date for primary outcome measure)
blood concentration of MTX [ Time Frame: up to 3 years ]
Same as current
Complete list of historical versions of study NCT01758666 on ClinicalTrials.gov Archive Site
other adverse reaction [ Time Frame: up to 3 years ]
Same as current
Not Provided
Not Provided
 
A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy
Not Provided

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteosarcoma
Drug: Methotrexate,Calcium folinate
Experimental: Methotrexate and Calcium folinate
Intervention: Drug: Methotrexate,Calcium folinate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
December 2016
November 2016   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
12 Years to 60 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01758666
CIH-WAC-201205001
Not Provided
Not Provided
Not Provided
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
Not Provided
Study Chair: Chen Wang Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP