Back to resultsApatinib Plus Radiotherapy for Patients With Brain Metastases From Non-small-cell Lung Cancer
Primary Purpose
Brain Metastases
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Apatinib plus radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain Metastases focused on measuring Brain Metastases
Eligibility Criteria
Inclusion Criteria:
- Aged 18 to 75 years old, males or females;.
- According to pathological and histological，the subjects were diagnosed with wild-type non-small-cell lung cancer patients from brain metastasis examinations;
- Subjects failed first-line standard chemotherapy ;
- Subjects expected survival of more than 3 months;
- Eastern Cooperative Oncology Group performance status :0-2 points;
The main organ function is normal, that is to meet the following standards:(1) Blood routine examination meets the following standards
a. Hemoglobin ≥90 g/L；b. Absolute Neutrophil Count≥1.5×10^9/L； c. Platelet ≥80×10^9/L； (2)Blood biochemistry examination meets the following standards
a.Total Bilirubin <1.5 times the upper normal limit；b.Glutamic transaminase <2.5 times the upper normal limit, glutamic-oxalacetic transaminase <2.5 times the upper normal limit， For patients with liver metastasis ,the Glutamic transaminase and glutamic-oxalacetic transaminase index is less than 5 times the upper normal limit c.Serum Cr was less than 1.25 times the upper normal limit
- Women of reproductive age must undergo urine tests to eliminate the possibility of pregnancy.During the period of treatment and within 8 weeks after the treatment, the subjects voluntarily adopted appropriate methods of contraception .
- Subjects volunteered to participate in this study and signed informed consent
Exclusion Criteria:
- Patients with meningeal metastasis;
- Patients with intracranial stroke;
- Previous toxicity associated with chemotherapy and / or radiotherapy persisted;
- Radiological evidence indicates the presence of an empty or necrotic tumor;
- Radiological evidence indicates the presence of a central tumor invading large blood vessels;
- Patients need to be treated with anticoagulants or antiplatelet drugs;
- The subjects with abnormal coagulation function and bleeding tendency (INR>1.5×ULN、APTT>1.5×ULN);during the past 6 months, the subjects experienced severe thrombosis or clinically related severe bleeding events;In the past 3 months, clinically significant hemoptysis occurred;the subjects had inherited bleeding or thrombosis tendency;
- Subjects with high blood pressure and whose blood pressure can not be reduced to normal range by antihypertensive drugs;
- Other investigators believe that patients are not eligible for inclusion
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Apatinib plus radiotherapy
Arm Description
Apatinib: Within 1 week before radiotherapy, the dose of Apatinib were 500mg/daily .During radiotherapy,the dose of Apatinib were 250mg/daily. After radiotherapy, if the subject did not have a level 3 or above adverse reaction, investigators consider increasing doses to 500mg. Radiotherapy: The subjects with 1 to 4 metastases receive stereotactic radiosurgery or stereotactic radiation therapy ,and the subjects with more than 4 metastases receive stereotactic radiosurgery plus whole-brain radiation therapy.
Outcomes
Primary Outcome Measures
The intracranial disease progression free survival time
To observe the intracranial disease progression free survival time of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients
Secondary Outcome Measures
Progression free survival time
Baseline to measured date of progression or death from any cause
Overall survival
Baseline to measured date of death from any cause
Disease control rate
Baseline to measured progressive disease
Objective response rate
Baseline to measured stable disease
Dosage changes of dexamethasone
To observe the change of the dosage of dexamethasone before and after treatment
Volume change rate of cerebral edema
To observe the change of volume change rate of cerebral edema
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Cognitive function screening ：Mini-mental state examination (MMSE)
The Mini-mental state examination checklist includes 30 problems. Answer the correct question, get 1 points, answer wrong or answer not know, get 0 points, the scale of the total score is 0-30. If the score is 27-30 points, cognitive function is normal; if the score is less than 27, there is cognitive dysfunction. If the score is 21-26 points, there is a mild cognitive impairment. If the score is 10-20 points, there is moderate cognitive impairment. If the score is 0-9 points, there is severe cognitive impairment.
Executive function testing：trail marking test（TMT）
The TMT, parts A and B, assesses psychomotor speed and executive function.The A part of the TMT test defined the time range of 0-180 seconds, and the greater the value was, the lower function; the B part of the TMT test defined the time range of 0-300 seconds, and the greater the value, the lower function.
Language function detection ：Hopkins verbal learning test-revised（HVLT-R）
The COWA tests verbal fluency and executive function.Within 1 minutes, the subjects say how many words contain one word or within the specified category, each acceptable word counts 1 points, and the repeated words are scored without repetition. The higher the score, the better the function.
Verbal learning and memory:Hopkins verbal learning test-revised（HVLT-R）
The HVLT-R assesses aspects of verbal learning and memory, including immediate recall, delayed recall, and delayed recognition.In the HVLT-R test, the range of learning score and delayed recall score was 0-12 points, and the greater the score, the better the function.
Full Information
NCT ID
NCT03356600
First Posted
November 1, 2017
Last Updated
December 7, 2017
Sponsor
Shanxi Province Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03356600
Brief Title
Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-small-cell Lung Cancer
Official Title
The Prospective,Single Arm, Exploratory Clinical Trial of Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-Small-cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2017 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanxi Province Cancer Hospital
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
To observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
Brain Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Apatinib plus radiotherapy
Arm Type
Experimental
Arm Description
Apatinib:
Within 1 week before radiotherapy, the dose of Apatinib were 500mg/daily .During radiotherapy,the dose of Apatinib were 250mg/daily.
After radiotherapy, if the subject did not have a level 3 or above adverse reaction, investigators consider increasing doses to 500mg.
Radiotherapy:
The subjects with 1 to 4 metastases receive stereotactic radiosurgery or stereotactic radiation therapy ,and the subjects with more than 4 metastases receive stereotactic radiosurgery plus whole-brain radiation therapy.
Intervention Type
Combination Product
Intervention Name(s)
Apatinib plus radiotherapy
Intervention Description
Apatinib:
Within 1 week before radiotherapy, the dose of Apatinib were 500mg/daily .During radiotherapy,the dose of Apatinib were 250mg/daily.
After radiotherapy, if the subject did not have a level 3 or above adverse reaction, investigators consider increasing doses to 500mg.
Radiotherapy:
The subjects with 1 to 4 metastases receive stereotactic radiosurgery or stereotactic radiation therapy ,and the subjects with more than 4 metastases receive stereotactic radiosurgery plus whole-brain radiation therapy
Primary Outcome Measure Information:
Title
The intracranial disease progression free survival time
Description
To observe the intracranial disease progression free survival time of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients
Time Frame
tumor assesment every 8 weeks,up to 24 months
Secondary Outcome Measure Information:
Title
Progression free survival time
Description
Baseline to measured date of progression or death from any cause
Time Frame
evaluated in 24 months since the treatment began
Title
Overall survival
Description
Baseline to measured date of death from any cause
Time Frame
the first day of treatment to death or last survival confirm date ,up to 24 months
Title
Disease control rate
Description
Baseline to measured progressive disease
Time Frame
tumor assesment every 8 weeks,up to 24 months
Title
Objective response rate
Description
Baseline to measured stable disease
Time Frame
tumor assesment every 8 weeks,up to 24 months
Title
Dosage changes of dexamethasone
Description
To observe the change of the dosage of dexamethasone before and after treatment
Time Frame
Dosage changes of dexamethasone every 8 weeks,up to 24 months
Title
Volume change rate of cerebral edema
Description
To observe the change of volume change rate of cerebral edema
Time Frame
Volume change rate of cerebral edema every 8 weeks,up to 24 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
To observe the safety of therapeutic schedule every 8 weeks,up to 24 months
Title
Cognitive function screening ：Mini-mental state examination (MMSE)
Description
The Mini-mental state examination checklist includes 30 problems. Answer the correct question, get 1 points, answer wrong or answer not know, get 0 points, the scale of the total score is 0-30. If the score is 27-30 points, cognitive function is normal; if the score is less than 27, there is cognitive dysfunction. If the score is 21-26 points, there is a mild cognitive impairment. If the score is 10-20 points, there is moderate cognitive impairment. If the score is 0-9 points, there is severe cognitive impairment.
Time Frame
Volume change rate of cerebral edema every 8 weeks,up to 24 months
Title
Executive function testing：trail marking test（TMT）
Description
The TMT, parts A and B, assesses psychomotor speed and executive function.The A part of the TMT test defined the time range of 0-180 seconds, and the greater the value was, the lower function; the B part of the TMT test defined the time range of 0-300 seconds, and the greater the value, the lower function.
Time Frame
Volume change rate of cerebral edema every 8 weeks,up to 24 months
Title
Language function detection ：Hopkins verbal learning test-revised（HVLT-R）
Description
The COWA tests verbal fluency and executive function.Within 1 minutes, the subjects say how many words contain one word or within the specified category, each acceptable word counts 1 points, and the repeated words are scored without repetition. The higher the score, the better the function.
Time Frame
these neurocognitive function tests assesment every 8 weeks,up to 24 months
Title
Verbal learning and memory:Hopkins verbal learning test-revised（HVLT-R）
Description
The HVLT-R assesses aspects of verbal learning and memory, including immediate recall, delayed recall, and delayed recognition.In the HVLT-R test, the range of learning score and delayed recall score was 0-12 points, and the greater the score, the better the function.
Time Frame
these neurocognitive function tests assesment every 8 weeks,up to 24 months
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:
Aged 18 to 75 years old, males or females;.
According to pathological and histological，the subjects were diagnosed with wild-type non-small-cell lung cancer patients from brain metastasis examinations;
Subjects failed first-line standard chemotherapy ;
Subjects expected survival of more than 3 months;
Eastern Cooperative Oncology Group performance status :0-2 points;
The main organ function is normal, that is to meet the following standards:(1) Blood routine examination meets the following standards
a. Hemoglobin ≥90 g/L；b. Absolute Neutrophil Count≥1.5×10^9/L； c. Platelet ≥80×10^9/L； (2)Blood biochemistry examination meets the following standards
a.Total Bilirubin <1.5 times the upper normal limit；b.Glutamic transaminase <2.5 times the upper normal limit, glutamic-oxalacetic transaminase <2.5 times the upper normal limit， For patients with liver metastasis ,the Glutamic transaminase and glutamic-oxalacetic transaminase index is less than 5 times the upper normal limit c.Serum Cr was less than 1.25 times the upper normal limit
Women of reproductive age must undergo urine tests to eliminate the possibility of pregnancy.During the period of treatment and within 8 weeks after the treatment, the subjects voluntarily adopted appropriate methods of contraception .
Subjects volunteered to participate in this study and signed informed consent
Exclusion Criteria:
Patients with meningeal metastasis;
Patients with intracranial stroke;
Previous toxicity associated with chemotherapy and / or radiotherapy persisted;
Radiological evidence indicates the presence of an empty or necrotic tumor;
Radiological evidence indicates the presence of a central tumor invading large blood vessels;
Patients need to be treated with anticoagulants or antiplatelet drugs;
The subjects with abnormal coagulation function and bleeding tendency (INR>1.5×ULN、APTT>1.5×ULN);during the past 6 months, the subjects experienced severe thrombosis or clinically related severe bleeding events;In the past 3 months, clinically significant hemoptysis occurred;the subjects had inherited bleeding or thrombosis tendency;
Subjects with high blood pressure and whose blood pressure can not be reduced to normal range by antihypertensive drugs;
Other investigators believe that patients are not eligible for inclusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongwei Li, Master Supervisor
Phone
13015301402
Email
ahead-sxzl7@hotmail.com
12. IPD Sharing Statement
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Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-small-cell Lung Cancer
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