NCT04178343

Tomotherapy for Leptomeningeal Metastases

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leptomeningeal Metastasis

Interventions

Type	Name	Description
RADIATION	tomotherapy	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).

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-10-24
• Completion: 2018-10-24
• First posted: 2019-11-26
• Last updated: 2019-11-26

Locations

1 site across 1 country: China