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Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases (SRTRBM)

Primary Purpose

Brain Metastases

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fractionated Stereotactic Radiotherapy
Temozolomide
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, fractionated stereotactic radiotherapy, temozolomide

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 Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Refractory Brain Metastases

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

Outcomes

Primary Outcome Measures

intracranial progress free survival rate
defined as no progress of the treated lesions and no distant progress in the brain

Secondary Outcome Measures

Overall survival rate
progress free survival rate
local control rate
disease control rate (DCR)
Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD
adverse event
assessed by CTCAE criteria, v4.0 and RTOG criteria of the central nervous system
causes of death
collect the data of causes of death and analyze

Full Information

First Posted
January 10, 2016
Last Updated
June 5, 2017
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Cancer Foundation, China
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1. Study Identification

Unique Protocol Identification Number
NCT02654106
Brief Title
Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases
Acronym
SRTRBM
Official Title
Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Refractory Brain Metastases: A Single-arm, Single-center Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical trial was designed to investigate the efficiency and toxicity of fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.
Detailed Description
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of FSRT plus TMZ 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, fractionated stereotactic radiotherapy, temozolomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Refractory Brain Metastases
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 Type
Radiation
Intervention Name(s)
Fractionated Stereotactic Radiotherapy
Other Intervention Name(s)
FSRT
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
TMZ
Intervention Description
concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/m2*5d, q28d, 6cycles
Primary Outcome Measure Information:
Title
intracranial progress free survival rate
Description
defined as no progress of the treated lesions and no distant progress in the brain
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Overall survival rate
Time Frame
up to 3 year
Title
progress free survival rate
Time Frame
up to 1 year
Title
local control rate
Time Frame
up to 1 year
Title
disease control rate (DCR)
Description
Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD
Time Frame
2-3 months after radiation
Title
adverse event
Description
assessed by CTCAE criteria, v4.0 and RTOG criteria of the central nervous system
Time Frame
from the day of radiation to the end of adjuvant TMZ，up to 6 months
Title
causes of death
Description
collect the data of causes of death and analyze
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.
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

Citations:
PubMed Identifier
30996008
Citation
Bi N, Ma Y, Xiao J, Zhang H, Xu Y, Tian Y, Li J, Zhang Y, Liu Q, Wang K, Deng L, Wang W, Chen X, Liu F, Zhao R, Yang S, Huang X, Yi J, Hu C, Li Y. A Phase II Trial of Concurrent Temozolomide and Hypofractionated Stereotactic Radiotherapy for Complex Brain Metastases. Oncologist. 2019 Sep;24(9):e914-e920. doi: 10.1634/theoncologist.2018-0702. Epub 2019 Apr 17.
Results Reference
derived

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Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases

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