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出境医 / 临床实验 / Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC

Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC

Study Description
Brief Summary:
Observe the effect os radiotherapy plus or not plus endostar in the treatment of brain metastasis in NSCLC

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: endostar Drug: Placebos Radiation: radiotherapy Phase 2

Detailed Description:
The investigators will observe the time controlled by the brain lesion after the test and the total survival time of the patients. Meanwhile, during each follow-up, the investigators will extract cerebrospinal fluid for genomic analysis of cerebrospinal fluid
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: arm a
This group is a placebo control group, and we will use radiation therapy plus Placebos as the control group for the study
 Drug: Placebos
saline solution
Other Name: negative control

Radiation: radiotherapy
radiotherapy
Experimental: arm b
This group belongs to the experimental group. We will use radiotherapy combined with endostar for treatment, so as to judge the efficacy of the medicine
 Drug: endostar
endostatin
Other Name: An antiangiogenic drug

Radiation: radiotherapy
radiotherapy
Outcome Measures
Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression of brain lesions, and the maximum evaluation time is 36 months ]
    the time from the start of treatment to the progression of the brain metastases, in months


Secondary Outcome Measures :
  1. Overall survival （OS） [ Time Frame: From date of randomization until the date of death, assessed up to 36 months ]
    the total survival time of the patient from the start of treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • NSCLC Brain metastasis

Exclusion Criteria:

  • KPS<60
Contacts and Locations

Contacts
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Contact: dong xiaorong, Dr 15071116896 zrg27@163.com

Locations
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China, Hubei
Union Hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: dong xiaorong, Dr         
Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
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Study Director: dong xiaorong, Dr china goverment
Tracking Information
First Submitted Date  ICMJE August 8, 2016
First Posted Date  ICMJE August 3, 2018
Last Update Posted Date August 3, 2018
Actual Study Start Date  ICMJE February 21, 2017
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2018) 		Progression Free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression of brain lesions, and the maximum evaluation time is 36 months ]
the time from the start of treatment to the progression of the brain metastases, in months
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2018) 		Overall survival （OS） [ Time Frame: From date of randomization until the date of death, assessed up to 36 months ]
the total survival time of the patient from the start of treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC
Official Title  ICMJE Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC
Brief Summary Observe the effect os radiotherapy plus or not plus endostar in the treatment of brain metastasis in NSCLC
Detailed Description The investigators will observe the time controlled by the brain lesion after the test and the total survival time of the patients. Meanwhile, during each follow-up, the investigators will extract cerebrospinal fluid for genomic analysis of cerebrospinal fluid
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: endostar
    endostatin
    Other Name: An antiangiogenic drug
  • Drug: Placebos
    saline solution
    Other Name: negative control
  • Radiation: radiotherapy
    radiotherapy
Study Arms  ICMJE
  • Placebo Comparator: arm a
    This group is a placebo control group, and we will use radiation therapy plus Placebos as the control group for the study
    Interventions:
    • Drug: Placebos
    • Radiation: radiotherapy
  • Experimental: arm b
    This group belongs to the experimental group. We will use radiotherapy combined with endostar for treatment, so as to judge the efficacy of the medicine
    Interventions:
    • Drug: endostar
    • Radiation: radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 29, 2018) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • NSCLC Brain metastasis

Exclusion Criteria:

  • KPS<60
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03614065
Other Study ID Numbers  ICMJE endobrain
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiaorong Dong, Wuhan Union Hospital, China
Study Sponsor  ICMJE Wuhan Union Hospital, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: dong xiaorong, Dr china goverment
PRS Account Wuhan Union Hospital, China
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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