NCT01860144

Brief Summary

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

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
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

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

Study Start

First participant enrolled

June 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

3.5 years

First QC Date

May 19, 2013

Last Update Submit

May 17, 2015

Conditions

Metastatic Colorectal Cancer

Keywords

bevacizumaboverall survivaladverse eventstumor resection rate

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    To evaluate the treatment response of bevacizumab in Chinese patients with mCRC in real clinical practice

    6 weeks

Secondary Outcomes (4)

  • overall survival

    3 months

  • progression free survival

    6 weeks

  • Proportion of patients with bevacizumab treatment discontinuation

    3 weeks

  • resection rate

    1 month

Study Arms (1)

bevacizumab

Patients with metastatic colorectal cancer who accept treatment with chemotherapy and bevacizumab

Drug: Bevacizumab

Interventions

BevacizumabDRUG
Also known as: avastin
bevacizumab

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

metastatic colorectal cancer patients accept bevacizumab

You may qualify if:

  • histologically confirmed metastatic colorectal cancer patients Having initiated treatment with bevacizumab

You may not qualify if:

  • non-metastatic colorectal cancer patients not recieved bevacizumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Lin Shen, M.D.

    Beijing Cancer Hopital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Shen, M.D.

CONTACT

861088196561lin100@medmail.com.cn

Jifang Gong, M.D.

CONTACT

861088196561gongjifang@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of GI oncology

Study Record Dates

First Submitted

May 19, 2013

First Posted

May 22, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

CN(1)