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Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis

NCT ID: NCT02590510

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Brief Summary

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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

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Conditions

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Meningeal Carcinomatosis

Keywords

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Intrathecal chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The small dose of group

The dose of methotrexate is 10 mg

Group Type EXPERIMENTAL

methotrexate

Intervention Type DRUG

The quantity of methotrexate is different in the two groups.

The high dose of group

The dose of methotrexate is 15 mg

Group Type ACTIVE_COMPARATOR

methotrexate

Intervention Type DRUG

The quantity of methotrexate is different in the two groups.

Interventions

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methotrexate

The quantity of methotrexate is different in the two groups.

Intervention Type DRUG

Other Intervention Names

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Intrathecal chemotherapy

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hui Bu

OTHER

Sponsor Role lead

Responsible Party

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Hui Bu

Study Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hui

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Central Contacts

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Hui Bu

Role: CONTACT

Phone: 86-13831106903

Email: [email protected]

Other Identifiers

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BH 001

Identifier Type: -

Identifier Source: org_study_id