Colorectal Cancer
Conditions
Keywords
Colorectal cancer, Adjuvant setting, Capecitabine, Oxaliplatin
Brief summary
This observational study evaluates the efficacy and safety of capecitabine in combination with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data were collected from each participant for up to 36 months or until disease recurrence.
Interventions
DRUGCapecitabine
Administered according to the Summary of Product Characteristics.
BIOLOGICALOxaliplatin
Administered according to the Summary of Product Characteristics.
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 participants, \>/= 18 years of age * Treatment in line with the currently approved indication in the Summary of Product Characteristics
Exclusion criteria
* Contraindications according to the current Summary of Product Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (Time to Event) | Up to 3 years | Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Percentage of Participants With Adverse Events | Up to 3 years | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
Countries
Slovakia
Participant flow
Pre-assignment details
Two participants were screening failures. 74 participants were assigned to the study and treated with study drug.
Participants by arm
| Arm | Count |
|---|---|
| Capecitabine + Oxaliplatin Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.
Capecitabine: Administered according to the Summary of Product Characteristics.
Oxaliplatin: Administered according to the Summary of Product Characteristics. | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Complete remission | 35 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Recurrence | 26 |
Baseline characteristics
| Characteristic | Capecitabine + Oxaliplatin |
|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 74 |
| serious Total, serious adverse events | 1 / 74 |
Outcome results
Primary
Disease-Free Survival (Time to Event)
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause).
Time frame: Up to 3 years
Population: Intent-to-treat (ITT) population included all participants treated with at least one dose of study drug. Here, number of participants analyzed is number evaluable for efficacy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Capecitabine + Oxaliplatin | Disease-Free Survival (Time to Event) | 25 months |
Secondary
Safety: Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Up to 3 years
Population: Safety population included all participants treated with at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine + Oxaliplatin | Safety: Percentage of Participants With Adverse Events | 39.19 percentage of participants |