NCT04178343CompletedNot Applicable
Tomotherapy for Leptomeningeal Metastases: a Single Arm, Single Center, Phase II Trial
Chinese Academy of Medical Sciences1 site in 1 country103 target enrollmentStarted: September 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- overall survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group A
Experimental
Meningeal Metastases, with or without brain metastases
Intervention: tomotherapy (Radiation)
Outcomes
Primary Outcomes
overall survival
Time Frame: up to 2 years
the time from radiation to death
Secondary Outcomes
- adverse event(up to 2 years)
- intracranial progress free survival(up to 1 year)
- local control(up to 1 year)
- progress free survival rate(up to 1 year)
Investigators
Jianping Xiao
Dr
Chinese Academy of Medical Sciences
Study Sites (1)
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