Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC

NCT ID: NCT03614065

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-21

Study Completion Date

2018-11-30

Brief Summary

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Observe the effect os radiotherapy plus or not plus endostar in the treatment of brain metastasis in NSCLC

Detailed Description

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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

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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arm a

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

saline solution

radiotherapy

Intervention Type RADIATION

radiotherapy

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

Group Type EXPERIMENTAL

endostar

Intervention Type DRUG

endostatin

radiotherapy

Intervention Type RADIATION

radiotherapy

Interventions

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endostar

endostatin

Intervention Type DRUG

Placebos

saline solution

Intervention Type DRUG

radiotherapy

radiotherapy

Intervention Type RADIATION

Other Intervention Names

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An antiangiogenic drug negative control

Eligibility Criteria

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Inclusion Criteria

* NSCLC Brain metastasis

Exclusion Criteria

* KPS\<60
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Xiaorong Dong

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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dong xiaorong, Dr

Role: STUDY_DIRECTOR

china goverment

Locations

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Union Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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dong xiaorong, Dr

Role: CONTACT

15071116896

Facility Contacts

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dong xiaorong, Dr

Role: primary

Other Identifiers

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endobrain

Identifier Type: -

Identifier Source: org_study_id

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