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

Status

Unknown

Conditions

Intervention / Treatment

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
Drug: methotrexate
The quantity of methotrexate is different in the two groups.
Other Names:
  • Intrathecal chemotherapy
Active Comparator: The high dose of group
The dose of methotrexate is 15 mg
Drug: methotrexate
The quantity of methotrexate is different in the two groups.
Other Names:
  • Intrathecal chemotherapy

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

Hui Bu

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

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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