An Observational Study of Bevacizumab in Chinese Patients... | NCT01860144

Studies
An Observational Study of Bevacizumab in Chinese Patients With Metastatic Colorectal Cancer

NCT01860144

Sponsor

Peking University

Status

Unknown status

Last Update Posted

May 19, 2015Estimated

Enrollment

250Estimated

Phase

Not provided

Conditions

Metastatic Colorectal Cancer

Interventions

Bevacizumab

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

May 2015

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 2012

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

May 19, 2013

First Submission Date that Met QC Criteria

May 21, 2013

First Posted Date

May 22, 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

May 17, 2015

Last Update Posted Date

May 19, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This observational, multicenter, prospective study will evaluate the use of bevacizumab in real clinical practice in chinese patients with metastatic colorectal cancer.

Detailed Description

Not provided

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 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bevacizumab		Patients with metastatic colorectal cancer who accept treatment with chemotherapy and bevacizumab	Drug: Bevacizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab	Drug		bevacizumab	avastin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate	To evaluate the treatment response of bevacizumab in Chinese patients with mCRC in real clinical practice	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
overall survival	OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost	3 months
progression free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histologically confirmed metastatic colorectal cancer patients Having initiated treatment with bevacizumab

Exclusion Criteria:

non-metastatic colorectal cancer patients not recieved bevacizumab

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

metastatic colorectal cancer patients accept bevacizumab

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lin Shen, M.D.	Contact	861088196561		lin100@medmail.com.cn
Jifang Gong, M.D.	Contact	861088196561		gongjifang@gmail.com

Overall Officials

Name	Affiliation	Role
Lin Shen, M.D.	Beijing Cancer Hopital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Cancer Hospital	Recruiting	Beijing	Beijing Municipality	100142	China

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided