NCT03614065

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

February 21, 2017

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

August 3, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

August 8, 2016

Last Update Submit

July 29, 2018

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS)

    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 Outcomes (1)

  • Overall survival （OS）

    From date of randomization until the date of death, assessed up to 36 months

Study Arms (2)

arm a

PLACEBO COMPARATOR

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

Drug: PlacebosRadiation: radiotherapy

arm b

EXPERIMENTAL

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: endostarRadiation: radiotherapy

Interventions

endostarDRUG

endostatin

Also known as: An antiangiogenic drug
arm b
PlacebosDRUG

saline solution

Also known as: negative control
arm a
radiotherapyRADIATION

radiotherapy

arm aarm b

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NSCLC Brain metastasis

You may not qualify if:

  • KPS\<60

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

endostar proteinRadiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • dong xiaorong, Dr

    china goverment

    STUDY DIRECTOR

Central Study Contacts

dong xiaorong, Dr

CONTACT

15071116896zrg27@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 3, 2018

Study Start

February 21, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

August 3, 2018

Record last verified: 2018-07

Locations

CN(1)