Tomotherapy for Leptomeningeal Metastases

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

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

Study Overview

• Status: Completed
• Conditions: Leptomeningeal Metastasis
• Intervention / Treatment: Radiation: tomotherapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Group A; Meningeal Metastases, with or without brain metastases

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	the time from radiation to death	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local control	the time from radiation to leptomeningeal lesion recurrence	up to 1 year
intracranial progress free survival	the time from radiation to leptomeningeal lesion recurrence and/or new brain metastases	up to 1 year
progress free survival rate	the time from radiation to any progression	up to 1 year
adverse event	acute and late toxicities	up to 2 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Jianping Xiao, Dr, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): October 24, 2018
• Study Completion (Actual): October 24, 2018

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: fractionated stereotactic radiotherapy; tomotherapy; leptomeningeal metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Meningeal Neoplasms; Neoplasm Metastasis; Meningeal Carcinomatosis
• Other Study ID Numbers: CSNO-2015-MSD01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No