An Observational Study of First-Line Bevacizumab (Avastin) With Fluoropyrimidine-Based Chemotherapy in Participants 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: May 19, 2016
Last verified: May 2016
  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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Percentage of participants with liver resection [ Time Frame: up to approximately 4 years ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: up to approximately 4 years ] [ Designated as safety issue: No ]

Enrollment: 351
Study Start Date: October 2012
Estimated Study Completion Date: June 2016
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

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: May 19, 2016
Health Authority: Taiwan: Food and Drugs Authority

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
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2016