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Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
endostar
Placebos
radiotherapy
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • NSCLC Brain metastasis

Exclusion Criteria:

  • KPS<60

Sites / Locations

  • Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

arm a

arm b

Arm Description

This group is a placebo control group, and we will use radiation therapy plus Placebos as the control group for the study

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

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
the time from the start of treatment to the progression of the brain metastases, in months

Secondary Outcome Measures

Overall survival （OS）
the total survival time of the patient from the start of treatment

Full Information

First Posted
August 8, 2016
Last Updated
July 29, 2018
Sponsor
Wuhan Union Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03614065
Brief Title
Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC
Official Title
Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
arm a
Arm Type
Placebo Comparator
Arm Description
This group is a placebo control group, and we will use radiation therapy plus Placebos as the control group for the study
Arm Title
arm b
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
endostar
Other Intervention Name(s)
An antiangiogenic drug
Intervention Description
endostatin
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
negative control
Intervention Description
saline solution
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
radiotherapy
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
the time from the start of treatment to the progression of the brain metastases, in months
Time Frame
From date of randomization until the date of first documented progression of brain lesions, and the maximum evaluation time is 36 months
Secondary Outcome Measure Information:
Title
Overall survival （OS）
Description
the total survival time of the patient from the start of treatment
Time Frame
From date of randomization until the date of death, assessed up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: NSCLC Brain metastasis Exclusion Criteria: KPS<60
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
dong xiaorong, Dr
Phone
15071116896
Email
zrg27@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dong xiaorong, Dr
Organizational Affiliation
china goverment
Official's Role
Study Director
Facility Information:
Facility Name
Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dong xiaorong, Dr

12. IPD Sharing Statement

Learn more about this trial

Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC

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