Tomotherapy for Leptomeningeal Metastases

Leptomeningeal Metastasis Clinical Trial

Official title:

Tomotherapy for Leptomeningeal Metastases: a Single Arm, Single Center, Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178343
• Other study ID #: CSNO-2015-MSD01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: October 24, 2018

Study information

• Verified date: November 2019
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for leptomeningeal metastases.

Description:

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy for leptomeningeal metastases, which are defined as leptomeningeal metastases with or without brain metatstases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 24, 2018
• Est. primary completion date: October 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologic or cytologic diagnosis of primary tumor and conformed meningeal metastases by enhanced MRI; KPS =60,or KPS =40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas; Age: 18-75 years old; Adequate organ function:WBC=4.0x109/L Neu = 1.5x109/L Hemoglobin = 110 g/L Platelets =100 x109/L Total bilirubin = 1.5x ULN AST and ALT = 1.5x ULN BUN and Cr: within the normal range.

Exclusion Criteria:

• Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia); unable or unwilling to comply with the study protocol; patients who are anticipated in other clinical trials of meningeal metastases; pregnant patients or female patients whose HCG is positive; unsuitable to participate in study, that in the opinion of the treating physician.

Related Conditions & MeSH terms

• Leptomeningeal Metastasis
• Meningeal Carcinomatosis
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Radiation:
• tomotherapy
the prescription of tomotherapy: whole brain radiation (WBRT) with 40Gy in 20 fractions and concurrent boost of 60Gy of the leptomeningeal metastases; WBRT of 50Gy in 25 fractions, with dose limitation of hippocampus and brain stem; c.TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles. d. Some patients received intrathecal chemotherapy (MTX+AraC+Dex) based on the cytology of cerebrospinal fluid (CSF).

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	the time from radiation to death	up to 2 years
Secondary	local control	the time from radiation to leptomeningeal lesion recurrence	up to 1 year
Secondary	intracranial progress free survival	the time from radiation to leptomeningeal lesion recurrence and/or new brain metastases	up to 1 year
Secondary	progress free survival rate	the time from radiation to any progression	up to 1 year
Secondary	adverse event	acute and late toxicities	up to 2 years