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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
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital Identifier:
First received: August 30, 2012
Last updated: December 21, 2015
Last verified: December 2012

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 Intervention
Drug: Methotrexate,Calcium folinate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

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

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

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methotrexate and Calcium folinate Drug: Methotrexate,Calcium folinate


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:

  Contacts and Locations
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Please refer to this study by its identifier: NCT01758666

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

Responsible Party: Tianjin Medical University Cancer Institute and Hospital Identifier: NCT01758666     History of Changes
Other Study ID Numbers: CIH-WAC-201205001
Study First Received: August 30, 2012
Last Updated: December 21, 2015

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 processed this record on May 22, 2017