Tomotherapy for Leptomeningeal Metastases
Not Applicable
Completed
- Conditions
- Leptomeningeal Metastasis
- Interventions
- Radiation: tomotherapy
- Registration Number
- NCT04178343
- Lead Sponsor
- Chinese Academy of Medical Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group A tomotherapy Meningeal Metastases, with or without brain metastases
- Primary Outcome Measures
Name Time Method overall survival up to 2 years the time from radiation to death
- Secondary Outcome Measures
Name Time Method local control up to 1 year the time from radiation to leptomeningeal lesion recurrence
progress free survival rate up to 1 year the time from radiation to any progression
adverse event up to 2 years acute and late toxicities
intracranial progress free survival up to 1 year the time from radiation to leptomeningeal lesion recurrence and/or new brain metastases
Trial Locations
- Locations (1)
Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China