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Tomotherapy for Refractory Brain Metastases (TRBM)

This study is currently recruiting participants.
Verified January 2017 by Jianping Xiao, Chinese Academy of Medical Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT03027544
First Posted: January 23, 2017
Last Update Posted: January 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jianping Xiao, Chinese Academy of Medical Sciences
  Purpose
This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for refractory brain metastases.

Condition Intervention
Brain Metastases Radiation: tomotherapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tomotherapy for Refractory Brain Metastases: a Single Arm, Single Center Phase II Trial

Further study details as provided by Jianping Xiao, Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: 2-3 months after radiation ]
    Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD


Secondary Outcome Measures:
  • Overall survival rate [ Time Frame: up to 3 years ]
  • progress free survival rate [ Time Frame: up to 1 year ]
  • local control rate [ Time Frame: up to 1 year ]
  • intracranial progress free survival rate [ Time Frame: up to 1 year ]
  • adverse event [ Time Frame: from the day of radiation, up to 6 months ]
  • cause of death [ Time Frame: from the day of radiation to death date, up to 5 years ]

Estimated Enrollment: 150
Actual Study Start Date: September 1, 2014
Estimated Study Completion Date: September 1, 2018
Estimated Primary Completion Date: September 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental arm

Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases.

Intervention:tomotherapy

Radiation: tomotherapy

Tomotherapy: The regular fraction modes were as follows: a. lesions≥3 cm:52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions<2cm:36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm: 40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem:50-60Gy/2.5-3Gy/20f; 3. multiple lesions with large lesion: whole brain radiation (WBRT) with 40Gy/2Gy/20f and concurrent boost of 60Gy/3Gy/20f of the lesions.

TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles.


Detailed Description:
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT; the lesion number is no less than 3; or the tumor volume is no smaller than 6cc; or tumor diameter is no shorter than 3cm; or uncontrolled brain tumor after whole brain radiotherapy(WBRT); or the tumor is adjacent to essential structures of the brain, such as brain stem, optic chiasma, optic tract, etc; 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 end-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.
    • The expected survival time is less than 3 months.
    • Patients who are anticipated in other clinical trials of brain metastases.
    • Patients who has been treated with SRT in other hospitals
    • Pregnant patients or female patients whose HCG is positive
    • Unsuitable to participate in study, that in the opinion of the treating physician.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027544


Contacts
Contact: Jianping Xiao 86-13811026919 jpxiao8@163.com

Locations
China, Beijing
Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Jianping Xiao    86-13811026919    jpxiao8@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Jianping Xiao Chinese Academy of Medical Sciences
  More Information

Responsible Party: Jianping Xiao, Dr, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03027544     History of Changes
Other Study ID Numbers: NCC2014 YZ-14
First Submitted: January 19, 2017
First Posted: January 23, 2017
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: the baseline characteristics and treatment plan can be shared with other researchers when the research paper has been published. The IPD will be sent by email if applied.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jianping Xiao, Chinese Academy of Medical Sciences:
multiple brain metastases
large brain metastases
meningeal metastases
tomotherapy

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases