N/A
Completed N=606
An Observational Study of Bevacizumab in Combination With 5-FU-Based Chemotherapy in Chinese Participants With Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT01319877 ↗Enrolled (actual)
606
Serious AEs
4.8%
Results posted
Sep 2016
Primary outcomePrimary: Percentage of Participants With Adverse Events — 76.4; 68.0 percentage of participants
Summary
This observational study will evaluate the safety and efficacy of Bevacizumab in combination with 5-Fluorouracil based chemotherapy as first-line and second-line therapy in Chinese participants with metastatic colorectal cancer. Data will be collected from each participant for up to 3 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events |
76.4; 68.0 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events |
4.9; 4.6 | — |
| PRIMARY Percentage of Participants With Adverse Events of Special Interest |
9.1; 5.9 | — |
| PRIMARY Percentage of Participants With Bevacizumab-Related Adverse Events |
54.5; 45.8 | — |
| PRIMARY Percentage of Participants With Bevacizumab-related Serious Adverse Events |
3.1; 2.0 | — |
| SECONDARY Percentage of Participants Achieving an Overall Response |
21.0; 10.5 | — |
| SECONDARY Progression-free Survival |
9.1; 8.1 | — |
| SECONDARY One-year Progression-free Survival Rate |
34.2; 29.9 | — |
| SECONDARY One-year Survival Rate |
68.7; 69.1 | — |
| SECONDARY Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup |
18.6; 10.3; 10.7; 4.8 | — |
| SECONDARY One-year Progression-free Survival Rate Per KRAS Subgroup |
45.2; 31.3; 19.5; 0 | — |
| SECONDARY One-year Survival Rate by the KRAS Subgroup |
81.0; 69.1; 57.9; 33.9 | — |
| SECONDARY Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup |
25.7; 15.2; 18.5; 10.9; 45.5; 14.3 | — |
| SECONDARY One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup |
38.9; 38.1; 29.1; 32.2; 13.3; 20.0 | — |
| SECONDARY One-year Survival Rate by the Chemotherapy Regimen Subgroup |
66.6; 71.6; 70.8; 71.4; 66.7; 20.8 | — |
| SECONDARY Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire |
63.68; 65.67; 62.89; 64.96; 59.79; 56.35 | — |
Eligibility Criteria
Inclusion Criteria
- Adult Chinese participants, >/= 18 years of age
- Histologically confirmed and previously untreated metastatic colorectal cancer
- Initiated on treatment with Bevacizumab (in combination with 5-FU based chemotherapy) according to locally approved Bevacizumab China package insert
- Documented participant with medical records
Exclusion Criteria
- Recent history of serious hemorrhage or hemoptysis of >/= 1/2 teaspoon of red blood
- Proteinuria at baseline (>/=2 grams / 24 hours)
- Major surgical procedure within 28 days prior to study treatment start, not fully healed wounds
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT01319877). 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.