Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis

Hui Bu

Status and phase: Unknown; Phase 4

Conditions: Meningeal Carcinomatosis

Treatments: Drug: methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT02590510

BH 001

Details and patient eligibility

About

The main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in the treatment of meningeal carcinomatosis.

Enrollment: 50 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

The small dose of group

Experimental group

Description:

The dose of methotrexate is 10 mg

Treatment:

Drug: methotrexate

The high dose of group

Active Comparator group

Description:

The dose of methotrexate is 15 mg

Treatment:

Drug: methotrexate