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Completed

NCT Number: NCT04178343

Tomotherapy for Leptomeningeal Metastases

This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for leptomeningeal metastases.

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Key information

Conditions

Leptomeningeal Metastasis Central Nervous System Neoplasms Meningeal Carcinomatosis Meningeal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tomotherapy

Radiation
  • 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 outcomes

  1. overall survival

    Time frame: up to 2 years

    the time from radiation to death

Secondary outcomes

  1. local control

    Time frame: up to 1 year

    the time from radiation to leptomeningeal lesion recurrence

  2. intracranial progress free survival

    Time frame: up to 1 year

    the time from radiation to leptomeningeal lesion recurrence and/or new brain metastases

  3. progress free survival rate

    Time frame: up to 1 year

    the time from radiation to any progression

  4. adverse event

    Time frame: up to 2 years

    acute and late toxicities

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 26, 2019
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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