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Tomotherapy for Refractory Brain Metastases (TRBM)

Primary Purpose

Brain Metastases

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tomotherapy
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring multiple brain metastases, large brain metastases, meningeal metastases, tomotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental arm

Arm Description

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

Outcomes

Primary Outcome Measures

Objective response rate
Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD

Secondary Outcome Measures

Overall survival rate
progress free survival rate
local control rate
intracranial progress free survival rate
adverse event
cause of death

Full Information

First Posted
January 19, 2017
Last Updated
January 19, 2017
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03027544
Brief Title
Tomotherapy for Refractory Brain Metastases
Acronym
TRBM
Official Title
Tomotherapy for Refractory Brain Metastases: a Single Arm, Single Center Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
September 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for refractory brain metastases.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
multiple brain metastases, large brain metastases, meningeal metastases, tomotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
tomotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate
Description
Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD
Time Frame
2-3 months after radiation
Secondary Outcome Measure Information:
Title
Overall survival rate
Time Frame
up to 3 years
Title
progress free survival rate
Time Frame
up to 1 year
Title
local control rate
Time Frame
up to 1 year
Title
intracranial progress free survival rate
Time Frame
up to 1 year
Title
adverse event
Time Frame
from the day of radiation, up to 6 months
Title
cause of death
Time Frame
from the day of radiation to death date, up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianping Xiao
Phone
86-13811026919
Email
jpxiao8@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianping Xiao
Organizational Affiliation
Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianping Xiao
Phone
86-13811026919
Email
jpxiao8@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Tomotherapy for Refractory Brain Metastases

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