Back to resultsHFSRT With Concurrent TMZ for Large BMs
Primary Purpose
Brain Metastases, Chemotherapy, Radiotherapy
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Temozolomide
hypofractionated radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain Metastases
Eligibility Criteria
Inclusion Criteria:
- histologic or cytological diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT;
- the number of BMs ≤ 3
- the tumor volume ≥6cc, or maximum diameter of BMs≥ 3cm;
- Karnofsky performance score (KPS)≥60, or KPS≥40 but simply caused by BMs;
- Age: 18-75 years old;
- Adequate function of major organs, and blood test reached the following level: WBC≥4.0x109/L, NEU≥1.5x109/L Hemoglobin≥110 g/L, Platelets≥100 x109/L; Liver function test results<1.5 times the institutional upper limit of normal (ULN); BUN and Cr: within the normal range.
Exclusion Criteria:
- patient with other clinically significant diseases (e.g. myocardial infarction within the past 6 months, severe arrhythmia);
- unable or unwilling to comply with the study protocol;
- patient whose survival expectancy was less than 3 months;
- the large BM locates in brainstem;
- patient who anticipated in other clinical trials of brain metastases;
- the large lesions have been treated with SRT in other hospitals;
- pregnant patients or female patients whose HCG is positive.
Sites / Locations
- Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CRT group
RT group
Arm Description
patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.
patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone.
Outcomes
Primary Outcome Measures
intracranial progression free survival (IPFS) rate
IPFS was defined as the interval from the beginning of radiation to any intracranial progression
Secondary Outcome Measures
local control rate
the control rate of treated lesions
Brain metastasis-specific survival (BMSS) rate
BMSS was defined as the internal from the beginning of RT to death caused by BM
overall survival (OS) rate
OS was defined as the internal from the beginning of RT to death caused by any reason
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and NRG/RTOG CNS toxicities criteria
the toxicities caused by RT and (or) Chemotherapy
Full Information
NCT ID
NCT03778541
First Posted
December 9, 2018
Last Updated
July 22, 2019
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03778541
Brief Title
HFSRT With Concurrent TMZ for Large BMs
Official Title
Hypofractionated Radiotherapy With Concurrent Temozolomide for Large Brain Metastases: a Multi-center Randomized Phase III Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
December 3, 2022 (Anticipated)
Study Completion Date
December 3, 2022 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A multi-center randomized phase III trial was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.
Detailed Description
A previous single arm phase II trial and propensity- matched study of our institution have shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control, intracranial progression free survival, progression free survival and overall survival rates were better than HFSRT alone group. Thus, the investigator conducted this randomized phase III trial to broad the sample size and verify our previous results. To finish the study in time, the investigator designed a multi-center trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Chemotherapy, Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
patients were randomized to 2 parallel groups, namely the concurrent chemoradiotherapy group and radiotherapy alone group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CRT group
Arm Type
Experimental
Arm Description
patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.
Arm Title
RT group
Arm Type
Active Comparator
Arm Description
patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
75mg/m2/d concurrent with radiotherapy, taken for at least 20 days.
Intervention Type
Radiation
Intervention Name(s)
hypofractionated radiotherapy
Intervention Description
the regular radiation dose prescription is 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.
Primary Outcome Measure Information:
Title
intracranial progression free survival (IPFS) rate
Description
IPFS was defined as the interval from the beginning of radiation to any intracranial progression
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
local control rate
Description
the control rate of treated lesions
Time Frame
up to 2 years
Title
Brain metastasis-specific survival (BMSS) rate
Description
BMSS was defined as the internal from the beginning of RT to death caused by BM
Time Frame
up to 2 years
Title
overall survival (OS) rate
Description
OS was defined as the internal from the beginning of RT to death caused by any reason
Time Frame
up to 2 years
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and NRG/RTOG CNS toxicities criteria
Description
the toxicities caused by RT and (or) Chemotherapy
Time Frame
acute toxicities: up to 3 months after RT; Late toxicities: up to 2 years after RT
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 cytological diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT;
the number of BMs ≤ 3
the tumor volume ≥6cc, or maximum diameter of BMs≥ 3cm;
Karnofsky performance score (KPS)≥60, or KPS≥40 but simply caused by BMs;
Age: 18-75 years old;
Adequate function of major organs, and blood test reached the following level: WBC≥4.0x109/L, NEU≥1.5x109/L Hemoglobin≥110 g/L, Platelets≥100 x109/L; Liver function test results<1.5 times the institutional upper limit of normal (ULN); BUN and Cr: within the normal range.
Exclusion Criteria:
patient with other clinically significant diseases (e.g. myocardial infarction within the past 6 months, severe arrhythmia);
unable or unwilling to comply with the study protocol;
patient whose survival expectancy was less than 3 months;
the large BM locates in brainstem;
patient who anticipated in other clinical trials of brain metastases;
the large lesions have been treated with SRT in other hospitals;
pregnant patients or female patients whose HCG is positive.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianping Xiao, Dr
Phone
+8613811026919
Email
jpxiao8@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianping Xiao, Dr
Organizational Affiliation
Cancer Institute and Hospital, 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, Dr
Phone
86-13811026919
Email
jpxiao8@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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HFSRT With Concurrent TMZ for Large BMs
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