We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Observational Study of First-Line Bevacizumab (Avastin) With Fluoropyrimidine-Based Chemotherapy in Participants With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01712347
First Posted: October 23, 2012
Last Update Posted: July 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This multicenter observational study will evaluate the efficacy and safety of first-line bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy in participants with metastatic colorectal cancer (mCRC). Participants for whom the treating physician has decided to initiate first-line fluoropyrimidine based chemotherapy in combination with bevacizumab will be observed for approximately 4 years.

Condition Intervention
Colorectal Cancer Drug: Bevacizumab Drug: Chemotherapy

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: Start of first line therapy until death (up to approximately 4 years) ]

Secondary Outcome Measures:
  • Progression-free survival from the time of starting first-line therapy, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria [ Time Frame: Start of first line therapy until death (up to approximately 4 years) ]
  • Percentage of participants with best overall response, assessed according to RECIST v.1.1 criteria [ Time Frame: Start of first line therapy until death (up to approximately 4 years) ]
  • Percentage of participants with liver resection [ Time Frame: up to approximately 4 years ]
  • Number of participants with adverse events [ Time Frame: up to approximately 4 years ]

Enrollment: 351
Study Start Date: October 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
mCRC Participants
mCRC participant will receive bevacizumab as per approved label with the approved first-line fluoropyrimidine based chemotherapy, as per physician discretion. The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.
Drug: Bevacizumab
Bevacizumab will be administered as per approved label.
Other Name: Avastin
Drug: Chemotherapy
The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with metastatic colorectal cancer receiving first-line bevacizumab in combination with fluoropyrimidine-based chemotherapy
Criteria

Inclusion Criteria:

  • Participants with histologically confirmed metastatic colorectal cancer who will receive bevacizumab in combination with first-line fluoropyrimidine-based chemotherapy

Exclusion Criteria:

  • Participants not qualified for bevacizumab treatment according to the local label
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712347


Locations
Taiwan
Chai Yi, Taiwan, 613
Kaohsiung, Taiwan, 00833
Kaohsiung, Taiwan, 807
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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01712347     History of Changes
Other Study ID Numbers: ML28233
First Submitted: October 19, 2012
First Posted: October 23, 2012
Last Update Posted: July 4, 2016
Last Verified: July 2016

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