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An Observational Study of Avastin (Bevacizumab) in Combination With 5-FU-Based Chemotherapy as First-Line Treatment in Chinese Patients With Metastatic Colorectal Cancer

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01319877
First received: March 18, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with 5-Fluorouracil based chemotherapy as first-line therapy in Chinese patients with metastatic colorectal cancer. Data will be collected from each patient for up to 3 years.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Avastin Plus 5-FU Based Chemotherapy as First Line Treatment for Chinese Patients With Metastatic Colorectal Cancer.

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate (according to RECIST criteria) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • One-year progression-free survival rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • One-year survival rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Correlation between KRAS status and clinical outcome (response/progression-free survival/survival) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Effect of chemotherapy regimens on clinical outcome (response/progression-free survival/survival) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-CR29 questionnaires [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with metastatic colorectal cancer receiving first-line therapy with Avastin in combination with 5-FU-based chemotherapy

Criteria

Inclusion Criteria:

  • Adult Chinese patients, >/= 18 years of age
  • Histologically confirmed and previously untreated metastatic colorectal cancer
  • Initiated on treatment with Avastin (in combination with 5-FU based chemotherapy) according to locally approved Avastin China package insert
  • Documented patient 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319877

Contacts
Contact: Please reference Study ID Number: ML25391 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
China
Recruiting
Beijing, China, 100071
Recruiting
Beijing, China, 100191
Recruiting
Changzhou, China, 213003
Recruiting
Chengdu, China, 610041
Recruiting
Fuzhou, China, 350014
Recruiting
Guangzhou, China, 510515
Recruiting
Guangzhou, China, 510655
Recruiting
Guangzhou, China, 510080
Recruiting
Hang Zhou, China, 310022
Recruiting
Hangzhou, China, 310009
Recruiting
Hangzhou, China, 310003
Recruiting
Harbin, China, 150040
Recruiting
Jiangsu, China, 210009
Recruiting
Jinan, China, 250117
Recruiting
Nanjing, China, 210029
Recruiting
Nanjing, China, 210002
Recruiting
Shanghai, China, 200032
Recruiting
Shanghai, China, 200003
Recruiting
Shenyang, China, 110001
Recruiting
Wuhan, China, 430079
Recruiting
Xian City, China, 710032
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01319877     History of Changes
Other Study ID Numbers: ML25391
Study First Received: March 18, 2011
Last Updated: May 7, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013