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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01319877
First received: March 18, 2011
Last updated: July 22, 2016
Last verified: July 2016
  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:


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 December 02, 2016