Back to resultsDifferent Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis
Primary Purpose
Meningeal Carcinomatosis
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Meningeal Carcinomatosis focused on measuring Intrathecal chemotherapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
The small dose of group
The high dose of group
Arm Description
The dose of methotrexate is 10 mg
The dose of methotrexate is 15 mg
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
The incidence of adverse reactions
In accordance with the standard of CTCAE, an assessment will be assessed every month
KPS score
In accordance with the standard of KPS(Karnofsky Performance Status,KPS) score, an assessment will be assessed every month
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02590510
Brief Title
Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hui Bu
4. Oversight
5. Study Description
Brief Summary
The main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in the treatment of meningeal carcinomatosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningeal Carcinomatosis
Keywords
Intrathecal chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The small dose of group
Arm Type
Experimental
Arm Description
The dose of methotrexate is 10 mg
Arm Title
The high dose of group
Arm Type
Active Comparator
Arm Description
The dose of methotrexate is 15 mg
Intervention Type
Drug
Intervention Name(s)
methotrexate
Other Intervention Name(s)
Intrathecal chemotherapy
Intervention Description
The quantity of methotrexate is different in the two groups.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
one year
Secondary Outcome Measure Information:
Title
The incidence of adverse reactions
Description
In accordance with the standard of CTCAE, an assessment will be assessed every month
Time Frame
one year
Title
KPS score
Description
In accordance with the standard of KPS(Karnofsky Performance Status,KPS) score, an assessment will be assessed every month
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Bu
Phone
86-13831106903
Email
buhuimy1@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui
Organizational Affiliation
The Second Hospital of Hebei Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis
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