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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01319877
First received: March 18, 2011
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This observational study will evaluate the safety and efficacy of Avastin (bevac izumab) in combination with 5-Fluorouracil based chemotherapy as first-line ther apy in Chinese patients with metastatic colorectal cancer. Data will be collecte d 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:


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
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 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
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 City, China, 213003
Chengdu, China, 610041
Fuzhou, China, 350014
Guangzhou, China, 510655
Guangzhou, China, 510515
Guangzhou, China, 510080
Hang Zhou, China, 310022
Hangzhou, China, 310009
HangzhouZhejiang, China, 310003
Harbin, China, 150040
Jiangsu, China, 210009
Jinan, China, 250117
Nanjing, China, 210029
Nanjing, China, 210002
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

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: October 6, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 29, 2014