Back to resultsTomotherapy for Leptomeningeal Metastases
Primary Purpose
Leptomeningeal Metastasis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tomotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Leptomeningeal Metastasis focused on measuring tomotherapy, leptomeningeal metastases, fractionated stereotactic radiotherapy
Eligibility Criteria
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.
Sites / Locations
- Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group A
Arm Description
Meningeal Metastases, with or without brain metastases
Outcomes
Primary Outcome Measures
overall survival
the time from radiation to death
Secondary Outcome Measures
local control
the time from radiation to leptomeningeal lesion recurrence
intracranial progress free survival
the time from radiation to leptomeningeal lesion recurrence and/or new brain metastases
progress free survival rate
the time from radiation to any progression
adverse event
acute and late toxicities
Full Information
NCT ID
NCT04178343
First Posted
November 25, 2019
Last Updated
November 25, 2019
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04178343
Brief Title
Tomotherapy for Leptomeningeal Metastases
Official Title
Tomotherapy for Leptomeningeal Metastases: a Single Arm, Single Center, Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
October 24, 2018 (Actual)
Study Completion Date
October 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for leptomeningeal metastases.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leptomeningeal Metastasis
Keywords
tomotherapy, leptomeningeal metastases, fractionated stereotactic radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Meningeal Metastases, with or without brain metastases
Intervention Type
Radiation
Intervention Name(s)
tomotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
overall survival
Description
the time from radiation to death
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
local control
Description
the time from radiation to leptomeningeal lesion recurrence
Time Frame
up to 1 year
Title
intracranial progress free survival
Description
the time from radiation to leptomeningeal lesion recurrence and/or new brain metastases
Time Frame
up to 1 year
Title
progress free survival rate
Description
the time from radiation to any progression
Time Frame
up to 1 year
Title
adverse event
Description
acute and late toxicities
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianping Xiao, Dr
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tomotherapy for Leptomeningeal Metastases
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