Leptomeningeal Metastasis
Conditions
Keywords
tomotherapy, leptomeningeal metastases, fractionated stereotactic radiotherapy
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.
Interventions
RADIATIONtomotherapy
1. the prescription of tomotherapy: whole brain radiation (WBRT) with 40Gy in 20 fractions and concurrent boost of 60Gy of the leptomeningeal metastases; 2. 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).
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | up to 2 years | the time from radiation to death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local control | up to 1 year | the time from radiation to leptomeningeal lesion recurrence |
| intracranial progress free survival | up to 1 year | the time from radiation to leptomeningeal lesion recurrence and/or new brain metastases |
| 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 |
Countries
China
Outcome results
None listed