Colorectal Cancer
Conditions
Brief summary
This prospective observational study will evaluate the safety and efficacy of Xeloda (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer. Patients will be followed until disease progression or unacceptable toxicity occurs.
Interventions
None listed
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 * Receiving Xeloda according to registered indication
Exclusion criteria
* Patients who are not eligible for Xeloda treatment according to the Summary of Product Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to end of study (up to 42 months) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Disease Progression | Baseline to progressive disease or death (up to 42 months) | Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline. |
| Progression-Free Survival (PFS) | Baseline to progressive disease or death (up to 42 months) | PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline. |
| Number of Participants With Hand-Foot Syndrome (HFS) | Baseline up to end of study (up to 42 months) | HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet. |
Countries
Serbia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| mCRC Participants Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent. | 258 |
| Total | 258 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Death | 1 |
| Overall Study | Disease Progression | 1 |
| Overall Study | Investigator Decision | 21 |
| Overall Study | Lost to Follow-up | 21 |
| Overall Study | Missing | 5 |
| Overall Study | Other | 10 |
| Overall Study | Withdrawal by Subject | 12 |
Baseline characteristics
| Characteristic | mCRC Participants |
|---|---|
| Age, Continuous | 65.38 Years STANDARD_DEVIATION 10.24 |
| Sex: Female, Male Female | 107 Participants |
| Sex: Female, Male Male | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 132 / 258 |
| serious Total, serious adverse events | 11 / 258 |
Outcome results
Primary
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.
Time frame: Baseline up to end of study (up to 42 months)
Population: Intent-to-treat (ITT) population included all participants who received at least one dose of the study drug and had a subsequent post baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mCRC Participants | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Non-Serious AEs | 132 Participants |
| mCRC Participants | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 11 Participants |
Secondary
Number of Participants With Hand-Foot Syndrome (HFS)
HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet.
Time frame: Baseline up to end of study (up to 42 months)
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mCRC Participants | Number of Participants With Hand-Foot Syndrome (HFS) | 79 Participants |
Secondary
Percentage of Participants With Disease Progression
Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.
Time frame: Baseline to progressive disease or death (up to 42 months)
Population: ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mCRC Participants | Percentage of Participants With Disease Progression | 70.8 Percentage of participants |
Secondary
Progression-Free Survival (PFS)
PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline.
Time frame: Baseline to progressive disease or death (up to 42 months)
Population: ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| mCRC Participants | Progression-Free Survival (PFS) | 4 Months |