An Observational Study of Avastin (Bevacizumab) With First-Line Fluoropyrimidine-Based Chemotherapy in 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:
NCT01712347
First received: October 19, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

This multicenter observational study will evaluate the efficacy and safety of fi rst-line Avastin (bevacizumab) in combination with fluoropyrimidine-based chemot herapy in patients with metastatic colorectal cancer. Patients will be followed for up to 3.5 years.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: AN OPEN-LABEL, MULTICENTER, NON-INTERVENTION, OBSERVATIONAL STUDY TO ASSESS THE EFFECT OF FIRST LINE BEVACIZUMAB TREATMENT WITH FLUOROPYRIMIDINE-BASED CHEMOTHERAPY (CTX) IN PATIENTS WITH METASTATIC COLORECTAL CANCER

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival from the time of starting first-line therapy [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival from the time of starting first-line therapy; tumor assessments according to RECIST v.1.1 criteria [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Overall response rate (ORR), tumor assessments according to RECIST v.1.1 criteria [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Liver resection rate in patients with liver metastasis only after the combination treatment with Avastin and any first-line fluoropyrimidine-based chemotherapy [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]

Enrollment: 351
Study Start Date: October 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (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 Avastin in combination with first-line fluoropyrimidine-based chemotherapy

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with histologically confirmed metastatic colorectal cancer who will receive Avastin in combination with first-line fluoropyrimidine-based chemotherapy

Exclusion Criteria:

  • Patients not qualified for Avastin treatment according to the local label
  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: NCT01712347

Locations
Taiwan
Chai Yi, Taiwan, 613
Kaohsiung, Taiwan, 807
Kaohsiung, Taiwan, 00833
Taichung, Taiwan, 407
Tainan, Taiwan, 704
Taipei, Taiwan, 00112
Taipei, Taiwan, 114
Taipei, Taiwan
Taoyuan, Taiwan, 333
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: NCT01712347     History of Changes
Other Study ID Numbers: ML28233
Study First Received: October 19, 2012
Last Updated: July 28, 2014
Health Authority: Taiwan: Food and Drugs Authority

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014