N/A
Completed N=210
An Observational Study on Bevacizumab (Avastin) as First-Line Treatment in Colorectal Cancer Participants With Potentially Resectable Liver Metastases
Source: ClinicalTrials.gov NCT01343901 ↗Enrolled (actual)
210
Serious AEs
33.8%
Results posted
Apr 2017
Primary outcomePrimary: Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery — 84.6 Percentage of participants
Summary
This observational study will evaluate the efficacy and safety of bevacizumab as first-line treatment in participants with colorectal cancer and potentially resectable liver metastases.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery |
84.6 | — |
| PRIMARY Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery |
4.4 | — |
| SECONDARY Percentage of Participants With at Least One Disease and Comorbidity at Day 0 |
7.5; 41.6; 13.9; 52.9 | — |
| SECONDARY Percentage of Participants With Different Previous Therapies at Day 0 |
29.1; 52.7 | — |
| SECONDARY Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period |
14.40 | — |
| SECONDARY Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period |
96.1 | — |
| SECONDARY Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment |
8.0; 10.9; 54.9; 4.0 | — |
| SECONDARY Percentage of Participants With Disease Progression or Death |
82.9 | — |
| SECONDARY Progression-free Survival (PFS) |
11.50 | — |
| SECONDARY Percentage of Participants With Disease Relapse |
76.1 | — |
| SECONDARY Relapse-free Survival (RFS) |
11.10 | — |
| SECONDARY Percentage of Participants Who Died |
41.0 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery |
4.3; 8.6; 7.1; 80.0; 1.3; 98.8 | — |
| SECONDARY Number of Cumulated Cycles of First Line Bevacizumab at Day 0 |
10.20 | — |
| SECONDARY Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0 |
94.9; 3.1; 2.0 | — |
| SECONDARY Total Duration of First Line Bevacizumab Treatment at Day 0 |
4.67 | — |
| SECONDARY Percentage of Participants With Unresectability Criteria |
81.6; 12.0; 10.5 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with colorectal cancer with exclusively hepatic or hepatic and pulmonary metastases
- First-line treatment with bevacizumab for potentially resectable metastatic disease
Exclusion Criteria
- Outright resectable disease
- Clearly inoperable disease
- Participation in a clinical trial evaluating a cytotoxic anticancer treatment and/or an innovative therapy
Data sourced from ClinicalTrials.gov (NCT01343901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.