An Observational Study of Bevacizumab in Combination With 5-FU-Based Chemotherapy in Chinese Participants With Metastatic Colorectal Cancer - Full Text View

Purpose

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.

Condition
Colorectal Cancer


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of Participants With Adverse Events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
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.
Percentage of Participants With Serious Adverse Events [ Time Frame: 36 months ] [ Designated as safety issue: No ]
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.
Percentage of Participants With Adverse Events of Special Interest [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Percentage of Participants With Bevacizumab-Related Adverse Events [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Percentage of Participants With Bevacizumab-related Serious Adverse Events [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of Participants Achieving an Overall Response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions.
Progression-free Survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Progression-free-survival (PFS) was defined as the time from the date when the participant signed the informed consent form to the time of first documented disease progression or death, whichever occurred first.
One-year Progression-free Survival Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year.
One-year Survival Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
One-year Progression-free Survival Rate Per KRAS Subgroup [ Time Frame: 1 year ] [ Designated as safety issue: No ]
One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
One-year Survival Rate by the KRAS Subgroup [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup [ Time Frame: Up to 36 Months ] [ Designated as safety issue: No ]
Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' chemotherapy regimen subgroup.
One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup [ Time Frame: 1 year ] [ Designated as safety issue: No ]
One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' chemotherapy regimen subgroup.
One-year Survival Rate by the Chemotherapy Regimen Subgroup [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire [ Time Frame: Up to 36 Months ] [ Designated as safety issue: No ]
Quality of life was assessed at baseline and every three months after treatment by the EORTC QLQ-C30 questionnaire. The possible score range was 0 to 100, with a higher score indicating better functioning.


Enrollment:	609
Study Start Date:	March 2011
Study Completion Date:	March 2015
Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts
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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Participants with metastatic colorectal cancer receiving first-line therapy with Bevacizumab in combination with 5-FU-based chemotherapy

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319877

Locations


China

Beijing, China, 100071

Beijing, China, 100083

Changzhou, China, 213003

Chengdu, China, 610041

Fuzhou, China, 350014

Guangzhou, China, 510080

Guangzhou, China, 510515

Guangzhou, China, 510655

Hangzhou, China, 310003

Hangzhou, China, 310009

Hangzhou, China, 310022

Harbin, China, 150040

Jinan, China, 250117

Nanjing, China, 210009

Nanjing, China, 210036

Nanjing, China

Nanning, China, 530021

Shanghai, China, 200003

Shanghai, China, 200032

Shenyang, China, 110001

Shenyang, China, 110042

Wuhan, China, 430079

Xi'an, China, 710032

Xiamen, China, 361004

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01319877 History of Changes
Other Study ID Numbers:	ML25391
Study First Received:	March 18, 2011
Results First Received:	April 21, 2016
Last Updated:	July 22, 2016
Health Authority:	China: Food and Drug Administration
Individual Participant Data
Plan to Share IPD:	No

Additional relevant MeSH terms:


Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases	Intestinal Diseases Rectal Diseases Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents

ClinicalTrials.gov processed this record on September 30, 2016