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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01758666
First received: August 30, 2012
Last updated: July 31, 2014
Last verified: December 2012

August 30, 2012
July 31, 2014
September 2012
November 2014   (final data collection date for primary outcome measure)
blood concentration of MTX [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
40
December 2014
November 2014   (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:

Both
12 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01758666
CIH-WAC-201205001
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