Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC

July 29, 2018 updated by: Xiaorong Dong, Wuhan Union Hospital, China
Observe the effect os radiotherapy plus or not plus endostar in the treatment of brain metastasis in NSCLC

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • NSCLC Brain metastasis

Exclusion Criteria:

  • KPS<60

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Radiation: radiotherapy
radiotherapy
Drug: Placebos
saline solution
Other Names:
  • negative control
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
Radiation: radiotherapy
radiotherapy
Drug: endostar
endostatin
Other Names:
  • An antiangiogenic drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of randomization until the date of first documented progression of brain lesions, and the maximum evaluation time is 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of randomization until the date of death, assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Investigators

  • Study Director: dong xiaorong, Dr, china goverment

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2017

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

August 8, 2016

First Submitted That Met QC Criteria

July 29, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

July 29, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • endobrain

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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