Colorectal Cancer
Conditions
Brief summary
This prospective observational study will evaluate the efficacy and safety of bevacizumab in combination with capecitabine and oxaliplatin as first-line treatment in participants with colorectal cancer. Data will be collected from each participant until disease progression occurs (for up to 30 months).
Interventions
BIOLOGICALBevacizumab
Bevacizumab administered according to prescribing information and normal clinical practice.
BIOLOGICALCapecitabine
Capecitabine administered according to prescribing information and normal clinical practice.
DRUGOxaliplatin
Capecitabine administered according to prescribing information and normal clinical practice.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Metastatic colorectal cancer * Treatment in accordance with current Summary of Product Characteristics and local guidelines
Exclusion criteria
* Contraindications according to current Summary of Product Characteristics and local guidelines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | From randomization to progression or death during the study (up to approximately 30 months) | Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate (Tumor Assessments According to RECIST) | Up to approximately 30 months | Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR |
| Percentage of Participants With Adverse Events | Up to approximately 30 months | An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
Countries
Slovakia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Not Eligible for Final Analysis | 5 |
| Overall Study | Participant's Request | 5 |
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Bevacizumab |
|---|---|
| Age, Continuous | 60.08 years STANDARD_DEVIATION 10.38 |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 39 / 63 |
| serious Total, serious adverse events | 2 / 63 |
Outcome results
Primary
Progression-free Survival
Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.
Time frame: From randomization to progression or death during the study (up to approximately 30 months)
Population: Includes enrolled participants who were evaluable for the primary endpoint analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab | Progression-free Survival | 7.000 months |
Secondary
Percentage of Participants With Adverse Events
An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to approximately 30 months
Population: Includes enrolled participants eligible for inclusion in the final analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab | Percentage of Participants With Adverse Events | 74.6 percentage of participants |
Secondary
Response Rate (Tumor Assessments According to RECIST)
Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR
Time frame: Up to approximately 30 months
Population: Includes enrolled participants who were evaluable for the primary endpoint analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab | Response Rate (Tumor Assessments According to RECIST) | Response Rate | 48.4 percentage of participants |
| Bevacizumab | Response Rate (Tumor Assessments According to RECIST) | Complete remission | 6.7 percentage of participants |
| Bevacizumab | Response Rate (Tumor Assessments According to RECIST) | Partial remission | 41.7 percentage of participants |