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)
Sponsor study identifier
observational
609
1 country
24
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
March 18, 2011
Actual (reported)March 22, 2011
Actual (reported)March 2015
Actual (reported)March 2015
Actual (reported)September 7, 2016
Actual (reported)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
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
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Participants with metastatic colorectal cancer receiving first-line therapy with Bevacizumab in combination with 5-FU-based chemotherapy
Beijing, 100071, China
Beijing, 100083, China
Changzhou, 213003, China
Chengdu, 610041, China
Fuzhou, 350014, China
Guangzhou, 510080, China
Guangzhou, 510515, China
Guangzhou, 510655, China
Clinical Trials
Hoffmann-La Roche
609 participants (actual enrollment reported by the registry).
First Submitted
March 18, 2011
First Posted
March 22, 2011
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Hangzhou, 310003, China
Hangzhou, 310009, China
Hangzhou, 310022, China
Harbin, 150040, China
Jinan, 250117, China
Nanjing, 210009, China
Nanjing, 210036, China
Nanjing, China
Nanning, 530021, China
Shanghai, 200003, China
Shanghai, 200032, China
Shenyang, 110001, China
Shenyang, 110042, China
Wuhan, 430079, China
Xi'an, 710032, China
Xiamen, 361004, China
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
September 7, 2016
Results First Posted
September 7, 2016
Record last verified: 2016-07
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Source: ClinicalTrials.gov.
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