- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02590510
Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis
October 27, 2016 updated by: Hui Bu
The main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in the treatment of meningeal carcinomatosis.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 14 or more
- a history of solid tumor
- a new clinical neurological signs and symptoms
- a typical CT(Computerized Tomography,CT) or MRI(Magnetic Resonance Imaging,MRI) imaging findings
- tumor cells in cerebrospinal fluid
Exclusion Criteria:
- KPS score <60
- the tumor patients with organ failure
- bacteria, fungi or viral meningitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The small dose of group
The dose of methotrexate is 10 mg
|
The quantity of methotrexate is different in the two groups.
Other Names:
|
Active Comparator: The high dose of group
The dose of methotrexate is 15 mg
|
The quantity of methotrexate is different in the two groups.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of adverse reactions
Time Frame: one year
|
In accordance with the standard of CTCAE, an assessment will be assessed every month
|
one year
|
KPS score
Time Frame: one year
|
In accordance with the standard of KPS(Karnofsky Performance Status,KPS) score, an assessment will be assessed every month
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hui, The Second Hospital of Hebei Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
October 26, 2015
First Submitted That Met QC Criteria
October 28, 2015
First Posted (Estimate)
October 29, 2015
Study Record Updates
Last Update Posted (Estimate)
October 28, 2016
Last Update Submitted That Met QC Criteria
October 27, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Meningeal Neoplasms
- Carcinoma
- Meningeal Carcinomatosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID Numbers
- BH 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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