search
Back to results

Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases

Primary Purpose

Brain Metastases

Status
Completed
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, Tomotherapy, fractionated stereotactic radiotheray

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;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, Totalbilirubin ≤ 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 WBRT. 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 Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group A

Arm Description

patients with multiple brain metastases (no less than 3 lesions) ,who have not recived whole brain radiotheray (WBRT).

Outcomes

Primary Outcome Measures

Disease control rate(DCR)
Using RTOG9508 criteria, tumor control is defined as CR+PR+SD

Secondary Outcome Measures

Overall survival
the time from radiation to death
progress free survival
the time from radiation to any progression
local control rate
the time from radiation to the treated brain metastases recurrence
intracranial progress free survival rate
the time from radiation to local recurrence and/or new brain metastases
adverse event
acute and late toxicities

Full Information

First Posted
November 25, 2019
Last Updated
November 25, 2019
Sponsor
Chinese Academy of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04178330
Brief Title
Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases
Official Title
Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases:A Single Arm, Single Center,Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
June 13, 2017 (Actual)
Study Completion Date
June 13, 2017 (Actual)

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
Yes

5. Study Description

Brief Summary
This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases.
Detailed Description
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases(≥3 lesions).

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, Tomotherapy, fractionated stereotactic radiotheray

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
patients with multiple brain metastases (no less than 3 lesions) ,who have not recived whole brain radiotheray (WBRT).
Intervention Type
Radiation
Intervention Name(s)
tomotherapy
Intervention Description
Whole brain radiation (WBRT) with 38-40Gy in 20 fractions and concurrent boost of 60-70Gy 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
Disease control rate(DCR)
Description
Using RTOG9508 criteria, tumor control is defined as CR+PR+SD
Time Frame
2-3 month after radiation
Secondary Outcome Measure Information:
Title
Overall survival
Description
the time from radiation to death
Time Frame
up to 3 years
Title
progress free survival
Description
the time from radiation to any progression
Time Frame
up to 1 year
Title
local control rate
Description
the time from radiation to the treated brain metastases recurrence
Time Frame
up to 1 year
Title
intracranial progress free survival rate
Description
the time from radiation to local recurrence and/or new brain metastases
Time Frame
up to 1 year
Title
adverse event
Description
acute and late toxicities
Time Frame
from the day of radiation, up to 3 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;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, Totalbilirubin ≤ 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 WBRT. Pregnant patients or female patients whose HCG is positive. Unsuitable to participate in study, that in the opinion of the treating physician.
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases

We'll reach out to this number within 24 hrs