NCT02590510

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

October 26, 2015

Last Update Submit

October 27, 2016

Conditions

Meningeal Carcinomatosis

Keywords

Intrathecal chemotherapy

Outcome Measures

Primary Outcomes (1)

  • overall survival

    one year

Secondary Outcomes (2)

  • The incidence of adverse reactions

    one year

  • KPS score

    one year

Study Arms (2)

The small dose of group

EXPERIMENTAL

The dose of methotrexate is 10 mg

Drug: methotrexate

The high dose of group

ACTIVE COMPARATOR

The dose of methotrexate is 15 mg

Drug: methotrexate

Interventions

methotrexateDRUG

The quantity of methotrexate is different in the two groups.

Also known as: Intrathecal chemotherapy
The high dose of groupThe small dose of group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meningeal Carcinomatosis

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Meningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hui

    The Second Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Bu

CONTACT

86-13831106903buhuimy1@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 29, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Last Updated

October 28, 2016

Record last verified: 2016-10