Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03614065
• Other study ID #: endobrain
• Status: Recruiting
• Phase: Phase 2
• Start date: February 21, 2017
• Est. completion date: November 2018

Study information

• Verified date: July 2018
• Source: Wuhan Union Hospital, China
• Contact: dong xiaorong, Dr
• Phone: 15071116896
• Email: zrg27[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• NSCLC Brain metastasis

Exclusion Criteria:

• KPS<60

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• endostar
endostatin
• Placebos
saline solution

Radiation:
• radiotherapy
radiotherapy

Locations

Country	Name	City	State
China	Union Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	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