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

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ClinicalTrials.gov Identifier: NCT01758666
Recruitment Status : Unknown
Verified December 2012 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 1, 2013
Last Update Posted : December 22, 2015
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

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.

Condition or disease Intervention/treatment
Osteosarcoma Drug: Methotrexate,Calcium folinate

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2012
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Methotrexate and Calcium folinate Drug: Methotrexate,Calcium folinate

Primary Outcome Measures :
  1. blood concentration of MTX [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. other adverse reaction [ Time Frame: up to 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758666

Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Study Chair: Chen Wang Tianjin Medical University Cancer Institute and Hospital

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01758666     History of Changes
Other Study ID Numbers: CIH-WAC-201205001
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2012

Additional relevant MeSH terms:
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Protective Agents
Vitamin B Complex