Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis

Phase 4

• Conditions: Meningeal Carcinomatosis
• Interventions: Drug: methotrexate

• Registration Number: NCT02590510
• Lead Sponsor: Hui Bu

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28
• Primary Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

• KPS score <60
• the tumor patients with organ failure
• bacteria, fungi or viral meningitis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The high dose of group	methotrexate	The dose of methotrexate is 15 mg
The small dose of group	methotrexate	The dose of methotrexate is 10 mg

Primary Outcome Measures

Name	Time	Method
overall survival	one year

Secondary Outcome Measures

Name	Time	Method
The incidence of adverse reactions	one year	In accordance with the standard of CTCAE, an assessment will be assessed every month
KPS score	one year	In accordance with the standard of KPS(Karnofsky Performance Status,KPS) score, an assessment will be assessed every month