An Observational Study of Bevacizumab in Combination With 5-FU-Based Chemotherapy in Chinese Participants With Metastatic Colorectal Cancer
A Multi-center Observational Study of Bevacizumab Plus 5-FU Based Chemotherapy as First Line and Second Line Treatment for Chinese Patients With Metastatic Colorectal Cancer (ML25391)
1 other identifier
observational
609
1 country
24
Brief Summary
This observational study will evaluate the safety and efficacy of Bevacizumab in combination with 5-Fluorouracil based chemotherapy as first-line and second-line therapy in Chinese participants with metastatic colorectal cancer. Data will be collected from each participant for up to 3 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2011
Longer than P75 for all trials
24 active sites
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
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 18, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
September 7, 2016
CompletedSeptember 7, 2016
July 1, 2016
4 years
March 18, 2011
April 21, 2016
July 22, 2016
Conditions
Outcome Measures
Primary Outcomes (5)
Percentage of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.
36 months
Percentage of Participants With Serious Adverse Events
A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose was fatal, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant, or required intervention to prevent one or other of the outcomes listed above.
36 months
Percentage of Participants With Adverse Events of Special Interest
36 months
Percentage of Participants With Bevacizumab-Related Adverse Events
36 months
Percentage of Participants With Bevacizumab-related Serious Adverse Events
36 months
Secondary Outcomes (11)
Percentage of Participants Achieving an Overall Response
36 months
Progression-free Survival
36 months
One-year Progression-free Survival Rate
1 year
One-year Survival Rate
1 year
Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup
36 months
- +6 more secondary outcomes
Study Arms (2)
First Line Treatment
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Second Line Treatment
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Eligibility Criteria
Participants with metastatic colorectal cancer receiving first-line therapy with Bevacizumab in combination with 5-FU-based chemotherapy
You may qualify if:
- Adult Chinese participants, \>/= 18 years of age
- Histologically confirmed and previously untreated metastatic colorectal cancer
- Initiated on treatment with Bevacizumab (in combination with 5-FU based chemotherapy) according to locally approved Bevacizumab China package insert
- Documented participant with medical records
You may not qualify if:
- Recent history of serious hemorrhage or hemoptysis of \>/= 1/2 teaspoon of red blood
- Proteinuria at baseline (\>/=2 grams / 24 hours)
- Major surgical procedure within 28 days prior to study treatment start, not fully healed wounds
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Beijing, 100071, China
Unknown Facility
Beijing, 100083, China
Unknown Facility
Changzhou, 213003, China
Unknown Facility
Chengdu, 610041, China
Unknown Facility
Fuzhou, 350014, China
Unknown Facility
Guangzhou, 510080, China
Unknown Facility
Guangzhou, 510515, China
Unknown Facility
Guangzhou, 510655, China
Unknown Facility
Hangzhou, 310003, China
Unknown Facility
Hangzhou, 310009, China
Unknown Facility
Hangzhou, 310022, China
Unknown Facility
Harbin, 150040, China
Unknown Facility
Jinan, 250117, China
Unknown Facility
Nanjing, 210009, China
Unknown Facility
Nanjing, 210036, China
Unknown Facility
Nanjing, China
Unknown Facility
Nanning, 530021, China
Unknown Facility
Shanghai, 200003, China
Unknown Facility
Shanghai, 200032, China
Unknown Facility
Shenyang, 110001, China
Unknown Facility
Shenyang, 110042, China
Unknown Facility
Wuhan, 430079, China
Unknown Facility
Xi'an, 710032, China
Unknown Facility
Xiamen, 361004, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2011
First Posted
March 22, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
September 7, 2016
Results First Posted
September 7, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share