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Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis

Sponsor
Hui Bu (Other)
Overall Status
Unknown status
CT.gov ID
NCT02590510
Collaborator
(none)
50
Enrollment
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Oct 1, 2015
Anticipated Primary Completion Date :
Oct 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. overall survival [one year]

    Secondary Outcome Measures

    1. The incidence of adverse reactions [one year]

      In accordance with the standard of CTCAE, an assessment will be assessed every month

    2. KPS score [one year]

      In accordance with the standard of KPS(Karnofsky Performance Status,KPS) score, an assessment will be assessed every month

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hui Bu

    Investigators

    • Principal Investigator: Hui, The Second Hospital of Hebei Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hui Bu, Study Principal Investigator, Hebei Medical University
    ClinicalTrials.gov Identifier:
    NCT02590510
    Other Study ID Numbers:
    • BH 001
    First Posted:
    Oct 29, 2015
    Last Update Posted:
    Oct 28, 2016
    Last Verified:
    Oct 1, 2016
    Keywords provided by Hui Bu, Study Principal Investigator, Hebei Medical University
    Intrathecal chemotherapy
    Additional relevant MeSH terms:
    Carcinoma
    Meningeal Carcinomatosis
    Methotrexate

    Study Results

    No Results Posted as of Oct 28, 2016