VEGFRs Predict Bevacizumab Benefit in Advanced Non Small... | NCT01891708

Studies
VEGFRs Predict Bevacizumab Benefit in Advanced Non Small Cell Lung Cancer

NCT01891708

Sponsor

Li Liu

Status

Unknown status

Last Update Posted

Jul 3, 2013Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Non Small Cell Lung Cancer
Brain Metastasis

Interventions

bevacizumab, standard chemotherapy and radiation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jun 19, 2013

First Submission Date that Met QC Criteria

Jul 2, 2013

First Posted Date

Jul 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2013

Last Update Posted Date

Jul 3, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

a. VEGFRs may be the biomarker which can predict the effect of bevacizumab in non small cell lung cancer

Detailed Description

non small cell lung cancer (non squamous carcinoma)
ECOG 0-1
from 18-75 years old

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab, standard chemotherapy and radiation	Other	the dose and application model of the three intervention are not specified by the sponsor who just observe the efficacy of the combination application of the three in non small cell lung cancer patients with brain metastasis once enrolled.		Drug:bevacizumab,also Avastine Drug:standard chemotherapy recommended by clinical guidlines Radiation

Measure	Description	Time Frame
PFS		6 months

Measure	Description	Time Frame
OS		18 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

non squamous cell non small cell lung cancer
with measurable disease
ECOG 0-1

Exclusion Criteria:

- patients received surgery in recent 4 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

advanced non small cell lung cancer patients with brain metastatic disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li Liu, MD	Contact	027-85872015		liulixiehe@163.com

Overall Officials

Name	Affiliation	Role
Li Liu, MD	Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Recruiting	Wuhan	Hubei	430071	China

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab
D011827	Radiation

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided