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 has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: March 18, 2011
Last updated: March 1, 2016
Last verified: March 2016
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.

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:

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 ]

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)


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

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
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Please refer to this study by its identifier: NCT01319877

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
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01319877     History of Changes
Other Study ID Numbers: ML25391 
Study First Received: March 18, 2011
Last Updated: March 1, 2016
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on August 25, 2016