Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Placebos; Drug: endostar; Radiation: radiotherapy

• Registration Number: NCT03614065
• Lead Sponsor: Wuhan Union Hospital, China

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

Study Timeline

• Study First Submitted: 2016-08-08
• Study Start: 2017-02-21
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-29
• Last Update Submitted: 2018-07-29
• Study First Posted: 2018-08-03
• Last Update Posted: 2018-08-03
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• NSCLC Brain metastasis

Exclusion Criteria

• KPS<60

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm a	Placebos	This group is a placebo control group, and we will use radiation therapy plus Placebos as the control group for the study
arm a	radiotherapy	This group is a placebo control group, and we will use radiation therapy plus Placebos as the control group for the study
arm b	radiotherapy	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
arm b	endostar	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

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	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

Secondary Outcome Measures

Name	Time	Method
Overall survival （OS）	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

Trial Locations

Locations (1)

Union Hospital; 🇨🇳 Wuhan, Hubei, China