Brain MetastasesPhase 2NCT03356600
Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-small-cell Lung Cancer
A Phase 2 study testing Apatinib plus radiotherapy in people with Brain Metastases, run by Shanxi Province Cancer Hospital.
Trial summary
To observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Apatinib plus radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Prospective,Single Arm, Exploratory Clinical Trial of Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-Small-cell Lung Cancer
To observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients
- Conditions
- Brain Metastases
- Being tested
- Apatinib plus radiotherapy
- Keywords
- Brain Metastases
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib plus radiotherapyCombination product
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
| Study group | Role | What they receive |
|---|---|---|
| Apatinib plus radiotherapy | Experimental | 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. Receives: Combination Product: Apatinib plus radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: tumor assesment every 8 weeks,up to 24 months
Secondary outcomes (11)
Progression free survival time
Baseline to measured date of progression or death from any cause
Measured: evaluated in 24 months since the treatment began
Overall survival
Baseline to measured date of death from any cause
Measured: the first day of treatment to death or last survival confirm date ,up to 24 months
Disease control rate
Baseline to measured progressive disease
Measured: tumor assesment every 8 weeks,up to 24 months
Objective response rate
Baseline to measured stable disease
Measured: tumor assesment every 8 weeks,up to 24 months
Dosage changes of dexamethasone
To observe the change of the dosage of dexamethasone before and after treatment
Measured: Dosage changes of dexamethasone every 8 weeks,up to 24 months
Volume change rate of cerebral edema
To observe the change of volume change rate of cerebral edema
Measured: Volume change rate of cerebral edema every 8 weeks,up to 24 months
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
Measured: To observe the safety of therapeutic schedule every 8 weeks,up to 24 months
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.
Measured: Volume change rate of cerebral edema every 8 weeks,up to 24 months
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.
Measured: Volume change rate of cerebral edema every 8 weeks,up to 24 months
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.
Measured: these neurocognitive function tests assesment every 8 weeks,up to 24 months
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.
Measured: these neurocognitive function tests assesment every 8 weeks,up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study startDec 2017 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Province Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356600
- Sponsor's protocol ID
- Ahead-SXZL 7
- Status last verified
- Nov 2017
- First submitted
- 1 Nov 2017
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective,Single Arm, Exploratory Clinical Trial of Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03356600
- Acronym / sponsor ID
- Ahead-SXZL 7
- Conditions
- Brain Metastases
- Keywords
- Brain Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Shanxi Province Cancer HospitalUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib plus radiotherapy | Experimental | Combination Product: Apatinib plus radiotherapyApatinib: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apatinib plus radiotherapyApatinib: 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 | Combination product | Apatinib plus radiotherapy |
Primary outcome
The intracranial disease progression free survival time
Time frame: tumor assesment every 8 weeks,up to 24 months
To observe the intracranial disease progression free survival time of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients
11 secondary outcomes
Progression free survival time
Time frame: evaluated in 24 months since the treatment began
Overall survival
Time frame: the first day of treatment to death or last survival confirm date ,up to 24 months
Disease control rate
Time frame: tumor assesment every 8 weeks,up to 24 months
Objective response rate
Time frame: tumor assesment every 8 weeks,up to 24 months
Dosage changes of dexamethasone
Time frame: Dosage changes of dexamethasone every 8 weeks,up to 24 months
Volume change rate of cerebral edema
Time frame: Volume change rate of cerebral edema every 8 weeks,up to 24 months
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
Cognitive function screening ：Mini-mental state examination (MMSE)
Time frame: Volume change rate of cerebral edema every 8 weeks,up to 24 months
Executive function testing：trail marking test（TMT）
Time frame: Volume change rate of cerebral edema every 8 weeks,up to 24 months
Language function detection ：Hopkins verbal learning test-revised（HVLT-R）
Time frame: these neurocognitive function tests assesment every 8 weeks,up to 24 months
Verbal learning and memory:Hopkins verbal learning test-revised（HVLT-R）
Time frame: these neurocognitive function tests assesment every 8 weeks,up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib plus radiotherapy in people with Brain Metastases, run by Shanxi Province Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongwei Li, Master Supervisor (13015301402, ahead-sxzl7@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The intracranial disease progression free survival time (time frame: tumor assesment every 8 weeks,up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.