An Observational Study of Avastin (Bevacizumab) With First-Line Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01712347
First received: October 19, 2012
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
This multicenter observational study will evaluate the efficacy and safety of first-line Avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy 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 ]
| Estimated Enrollment: | 350 |
| 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) |
| Groups/Cohorts |
|---|
| Cohort |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712347
Contacts
| Contact: Reference Study ID Number: ML28233 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global.rochegenentechtrials@roche.com |
Locations
| Taiwan | |
| Recruiting | |
| Chai Yi, Taiwan, 613 | |
| Recruiting | |
| Kaohsiung, Taiwan, 00833 | |
| Recruiting | |
| Kaohsiung, Taiwan, 807 | |
| Recruiting | |
| Taichung, Taiwan, 407 | |
| Recruiting | |
| Tainan, Taiwan, 704 | |
| Recruiting | |
| Taipei, Taiwan, 00112 | |
| Recruiting | |
| Taipei, Taiwan | |
| Recruiting | |
| Taipei, Taiwan, 114 | |
| Recruiting | |
| 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: | May 23, 2013 |
| 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 May 23, 2013