Back to resultsA Clinical Trial on Whole-brain Radiotherapy With Temozolomide Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases
Primary Purpose
Brain Metastasis, Radiation Therapy Complication
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TMZ
WBRT with avoidance of hippocampus
WBRT without avoidance of hippocampus
Sponsored by
About this trial
This is an interventional treatment trial for Brain Metastasis focused on measuring brain metastasis, whole-brain radiotherapy, TMZ, avoidance of hippocampus
Eligibility Criteria
Inclusion Criteria:
- Primary lesions diagnosed by pathology or cytology
- Brain metastases confirmed by brain MRI or CT(>3 brain metastases）
- Brain metastases beyond 5mm of hippocampus
- Male or female patients with age between 18 and 75 years old
- Karnofsky Performance Scores ≥ 60
- Expected survival ≥ 6 months
- No previous brain surgery or brain radiotherapy
- Without dysfunction of heart, lung, liver, kidney and hematopoiesis
- The primary carcinoma is under control
Exclusion Criteria:
- MMSE score <27
- Dysfunction of heart, lung, liver, kidney or hematopoiesis
- Severe neurological, mental or endocrine diseases
- History of alcohol or drug abuse within 3 months
- Visual or hearing dysfunction, low education level, or other reasons leading to not capable of taking the MMSE test
- Currently under treatment may effect patients' neurocognitive functions
- Patients participated in clinical trials of other drugs within last 3 months
- Other unsuitable reason
Sites / Locations
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
- Guangdong Three Nine Brain Hospital
- Guangzhou First People's Hospital
- Guangzhou People's Liberation Army Hospital 421
- Panyu Central Hospital
- The First Affiliated Hospital, Jinan University
- The Affiliated Cancer Hospital Of Guangzhou Medical Collage
- Guangdong Provincial Hospital Of Chinese Medicine
- The First Affiliated Hospital Of Guangzhou Medical Collage
- The Fifth Affiliated Hospital, Sun Yat-Sen University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
WBRT
WBRT with avoidance of hippocampus
WBRT with TMZ
WBRT with avoidance of hippocampus and TMZ
Arm Description
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy without avoidance of hippocampus applied.
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus applied.
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied.
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus and concurrent TMZ chemotherapy applied.
Outcomes
Primary Outcome Measures
Change of neurocognitive function between baseline and 4 months after radiotherapy
Neurocognitive function is evaluated by Minimum Mental State Examination (MMSE)
Secondary Outcome Measures
Effect on response rate
Response is evaluated on basis of RECIST
The tolerance of radiotherapy with TMZ concurrent chemotherapy
Adverse effects are evaluated by CTCAE 4.0 criteria
Full Information
NCT ID
NCT02832635
First Posted
June 14, 2016
Last Updated
July 11, 2016
Sponsor
Sun Yat-sen University
Collaborators
Fifth Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT02832635
Brief Title
A Clinical Trial on Whole-brain Radiotherapy With Temozolomide Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases
Official Title
Effectiveness and Safety of Whole-brain Radiotherapy With/Without TMZ Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases: a Multi-institutional, Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Fifth Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects on neurocognitive function of whole-brain radiotherapy (WBRT) with/without TMZ concurrent chemotherapy or avoidance of hippocampus for patients of brain metastases, as well as the feasibility and risk of avoidance of hippocampus during whole-brain radiotherapy.
Detailed Description
This is a phase II randomized clinical trial. It is reported that avoidance of hippocampus during whole-brain radiotherapy (WBRT) had benefits in preservation of memory for patients, and the use of concurrent TMZ in radiotherapy for patients with brain metastases benefited for treating outcome.
The purpose of this study is to evaluate the effects on neurocognitive function of whole-brain radiotherapy with/without TMZ concurrent chemotherapy or avoidance of hippocampus for patients of brain metastases, as well as the feasibility and risk of avoidance of hippocampus during whole-brain radiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastasis, Radiation Therapy Complication
Keywords
brain metastasis, whole-brain radiotherapy, TMZ, avoidance of hippocampus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WBRT
Arm Type
Experimental
Arm Description
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy without avoidance of hippocampus applied.
Arm Title
WBRT with avoidance of hippocampus
Arm Type
Experimental
Arm Description
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus applied.
Arm Title
WBRT with TMZ
Arm Type
Experimental
Arm Description
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied.
Arm Title
WBRT with avoidance of hippocampus and TMZ
Arm Type
Experimental
Arm Description
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus and concurrent TMZ chemotherapy applied.
Intervention Type
Drug
Intervention Name(s)
TMZ
Other Intervention Name(s)
temozolomide
Intervention Description
TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy
Intervention Type
Radiation
Intervention Name(s)
WBRT with avoidance of hippocampus
Intervention Description
Whole brain radiotherapy of 30Gy/10f by IMRT (Intensity Modulation Radiated Therapy), with or without boost. The maximum dose of hippocampus should be no more than 18Gy.
Intervention Type
Radiation
Intervention Name(s)
WBRT without avoidance of hippocampus
Intervention Description
Whole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered.
Primary Outcome Measure Information:
Title
Change of neurocognitive function between baseline and 4 months after radiotherapy
Description
Neurocognitive function is evaluated by Minimum Mental State Examination (MMSE)
Time Frame
baseline; four months after radiotherapy
Secondary Outcome Measure Information:
Title
Effect on response rate
Description
Response is evaluated on basis of RECIST
Time Frame
baseline; One, two, four, six, and twelve months after radiotherapy
Title
The tolerance of radiotherapy with TMZ concurrent chemotherapy
Description
Adverse effects are evaluated by CTCAE 4.0 criteria
Time Frame
baseline; once a week through during radiotherapy, up to 3 weeks
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:
Primary lesions diagnosed by pathology or cytology
Brain metastases confirmed by brain MRI or CT(>3 brain metastases）
Brain metastases beyond 5mm of hippocampus
Male or female patients with age between 18 and 75 years old
Karnofsky Performance Scores ≥ 60
Expected survival ≥ 6 months
No previous brain surgery or brain radiotherapy
Without dysfunction of heart, lung, liver, kidney and hematopoiesis
The primary carcinoma is under control
Exclusion Criteria:
MMSE score <27
Dysfunction of heart, lung, liver, kidney or hematopoiesis
Severe neurological, mental or endocrine diseases
History of alcohol or drug abuse within 3 months
Visual or hearing dysfunction, low education level, or other reasons leading to not capable of taking the MMSE test
Currently under treatment may effect patients' neurocognitive functions
Patients participated in clinical trials of other drugs within last 3 months
Other unsuitable reason
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun-fei Xia, Professor
Phone
86-13602805461
Email
xiayf@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohui Wang, MD
Phone
86-18826260661
Email
wangxh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-fei Xia, Professor
Organizational Affiliation
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun-fei Xia, Professor
Phone
86-13602805461
Email
xiayf@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Xiaohui Wang, MD
Phone
86-18826260661
Email
wangxh@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Yun-fei Xia, Professor
First Name & Middle Initial & Last Name & Degree
Xiaohui Wang, MD
Facility Name
Guangdong Three Nine Brain Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin-bo Cai, Prof.
Phone
86-13503030491
First Name & Middle Initial & Last Name & Degree
Linbo Cai, Prof.
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo-long Liu, Prof.
Phone
86-13802527172
First Name & Middle Initial & Last Name & Degree
Guo-long Liu, Prof.
Facility Name
Guangzhou People's Liberation Army Hospital 421
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Si-Lang Zhou, Prof.
Phone
86-13189099597
First Name & Middle Initial & Last Name & Degree
Si-Lang Zhou, Prof.
Facility Name
Panyu Central Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao-long Cao, Prof.
Phone
86-18922238053
First Name & Middle Initial & Last Name & Degree
Xiao-long Cao, Prof.
Facility Name
The First Affiliated Hospital, Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-ou Wang, Prof.
Phone
86-13602751067
First Name & Middle Initial & Last Name & Degree
Yi-ou Wang, Prof.
Facility Name
The Affiliated Cancer Hospital Of Guangzhou Medical Collage
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xun-fan Shao, Prof.
Phone
+86-13902770926
Email
xunfanshao@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Xun-fan Shao, Prof.
Facility Name
Guangdong Provincial Hospital Of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gong Li, Prof.
Phone
+86-13802915171
Email
leegong@21cn.com
First Name & Middle Initial & Last Name & Degree
Gong Li, Prof.
Facility Name
The First Affiliated Hospital Of Guangzhou Medical Collage
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dao-li Niu, Prof.
Phone
+86-13711101855
Email
daoliniu@163.com
First Name & Middle Initial & Last Name & Degree
Dao-li Niu, Prof.
Facility Name
The Fifth Affiliated Hospital, Sun Yat-Sen University
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhibin Cheng, Professor
Phone
86-13926946708
First Name & Middle Initial & Last Name & Degree
Zhibin Cheng, Professor
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial on Whole-brain Radiotherapy With Temozolomide Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases
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