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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Colorectal Cancer

Study Design

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Study Type :	Observational
Actual Enrollment :	609 participants
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)
Study Start Date :	March 2011
Actual Primary Completion Date :	March 2015
Actual Study Completion Date :	March 2015

Groups and Cohorts

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Group/Cohort
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.

Outcome Measures

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Primary Outcome Measures :

1. Percentage of Participants With Adverse Events [ Time Frame: 36 months ]
   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.
2. Percentage of Participants With Serious Adverse Events [ Time Frame: 36 months ]
   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.
3. Percentage of Participants With Adverse Events of Special Interest [ Time Frame: 36 months ]
4. Percentage of Participants With Bevacizumab-Related Adverse Events [ Time Frame: 36 months ]
5. Percentage of Participants With Bevacizumab-related Serious Adverse Events [ Time Frame: 36 months ]

Secondary Outcome Measures :

1. Percentage of Participants Achieving an Overall Response [ Time Frame: 36 months ]
   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.
2. Progression-free Survival [ Time Frame: 36 months ]
   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.
3. One-year Progression-free Survival Rate [ Time Frame: 1 year ]
   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.
4. One-year Survival Rate [ Time Frame: 1 year ]
5. Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup [ Time Frame: 36 months ]
   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.
6. One-year Progression-free Survival Rate Per KRAS Subgroup [ Time Frame: 1 year ]
   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.
7. One-year Survival Rate by the KRAS Subgroup [ Time Frame: 1 year ]
8. Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup [ Time Frame: Up to 36 Months ]
   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.
9. One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup [ Time Frame: 1 year ]
   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.
10. One-year Survival Rate by the Chemotherapy Regimen Subgroup [ Time Frame: 1 year ]
11. Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire [ Time Frame: Up to 36 Months ]
    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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01319877 History of Changes
Other Study ID Numbers:	ML25391
First Posted:	March 22, 2011
Results First Posted:	September 7, 2016
Last Update Posted:	September 7, 2016
Last Verified:	July 2016
Individual Participant Data (IPD) Sharing Statement:
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