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Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-small-cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03356600
Recruitment Status : Not yet recruiting
First Posted : November 29, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Shanxi Province Cancer Hospital

Brief Summary:
To observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients

Condition or disease Intervention/treatment Phase
Brain Metastases Combination Product: Apatinib plus radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Prospective,Single Arm, Exploratory Clinical Trial of Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-Small-cell Lung Cancer
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Apatinib plus radiotherapy

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.

Combination Product: Apatinib plus radiotherapy

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 Measures :
  1. 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


Secondary Outcome Measures :
  1. Progression free survival time [ Time Frame: evaluated in 24 months since the treatment began ]
    Baseline to measured date of progression or death from any cause

  2. Overall survival [ Time Frame: the first day of treatment to death or last survival confirm date ,up to 24 months ]
    Baseline to measured date of death from any cause

  3. Disease control rate [ Time Frame: tumor assesment every 8 weeks,up to 24 months ]
    Baseline to measured progressive disease

  4. Objective response rate [ Time Frame: tumor assesment every 8 weeks,up to 24 months ]
    Baseline to measured stable disease

  5. Dosage changes of dexamethasone [ Time Frame: Dosage changes of dexamethasone every 8 weeks,up to 24 months ]
    To observe the change of the dosage of dexamethasone before and after treatment

  6. Volume change rate of cerebral edema [ Time Frame: Volume change rate of cerebral edema every 8 weeks,up to 24 months ]
    To observe the change of volume change rate of cerebral edema

  7. 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 ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  8. Cognitive function screening :Mini-mental state examination (MMSE) [ Time Frame: Volume change rate of cerebral edema every 8 weeks,up to 24 months ]
    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.

  9. Executive function testing:trail marking test(TMT) [ Time Frame: Volume change rate of cerebral edema every 8 weeks,up to 24 months ]
    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.

  10. Language function detection :Hopkins verbal learning test-revised(HVLT-R) [ Time Frame: these neurocognitive function tests assesment every 8 weeks,up to 24 months ]
    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.

  11. 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 ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18 to 75 years old, males or females;.
  2. According to pathological and histological,the subjects were diagnosed with wild-type non-small-cell lung cancer patients from brain metastasis examinations;
  3. Subjects failed first-line standard chemotherapy ;
  4. Subjects expected survival of more than 3 months;
  5. Eastern Cooperative Oncology Group performance status :0-2 points;
  6. 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

  7. 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 .
  8. Subjects volunteered to participate in this study and signed informed consent

Exclusion Criteria:

  1. Patients with meningeal metastasis;
  2. Patients with intracranial stroke;
  3. Previous toxicity associated with chemotherapy and / or radiotherapy persisted;
  4. Radiological evidence indicates the presence of an empty or necrotic tumor;
  5. Radiological evidence indicates the presence of a central tumor invading large blood vessels;
  6. Patients need to be treated with anticoagulants or antiplatelet drugs;
  7. 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;
  8. Subjects with high blood pressure and whose blood pressure can not be reduced to normal range by antihypertensive drugs;
  9. Other investigators believe that patients are not eligible for inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356600


Contacts
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Contact: Hongwei Li, Master Supervisor 13015301402 ahead-sxzl7@hotmail.com

Sponsors and Collaborators
Shanxi Province Cancer Hospital

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Responsible Party: Shanxi Province Cancer Hospital
ClinicalTrials.gov Identifier: NCT03356600     History of Changes
Other Study ID Numbers: Ahead-SXZL 7
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanxi Province Cancer Hospital:
Brain Metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplasms by Site
Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action