Tomotherapy for Leptomeningeal Metastases

NCT04178343 | Completed DMC

• 1 other identifier: CSNO-2015-MSD01
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Leptomeningeal Metastasis

Keywords

tomotherapy; leptomeningeal metastases; fractionated stereotactic radiotherapy

Outcome Measures

Primary Outcomes (1)

• overall survival

  the time from radiation to death

  up to 2 years

Secondary Outcomes (4)

• local control

  up to 1 year

• intracranial progress free survival

  up to 1 year

• progress free survival rate

  up to 1 year

• adverse event

  up to 2 years

Study Arms (1)

Group A

EXPERIMENTAL

Meningeal Metastases, with or without brain metastases

Radiation: tomotherapy

Interventions

tomotherapy RADIATION

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).

Group A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Meningeal Carcinomatosis

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Jianping Xiao, Dr

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 26, 2019
• Study Start: September 1, 2014
• Primary Completion: October 24, 2018
• Study Completion: October 24, 2018
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)