Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis

Meningeal Carcinomatosis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02590510
• Other study ID #: BH 001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 26, 2015
• Last updated: October 27, 2016
• Start date: October 2015

Study information

• Verified date: October 2016
• Source: Hebei Medical University
• Contact: Hui Bu
• Phone: 86-13831106903
• Email: buhuimy1[@]163.com
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Meningeal Carcinomatosis

Intervention

Drug:
• methotrexate
The quantity of methotrexate is different in the two groups.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hui Bu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		one year	No
Secondary	The incidence of adverse reactions	In accordance with the standard of CTCAE, an assessment will be assessed every month	one year	Yes
Secondary	KPS score	In accordance with the standard of KPS(Karnofsky Performance Status,KPS) score, an assessment will be assessed every month	one year	No