Colorectal Cancer
Conditions
Brief summary
This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Interventions
DRUGcapecitabine [Xeloda]
1250mg/m2 po bid on days 1-14 of each 3 week cycle
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * colon cancer (Dukes stage C); * surgery, with no evidence of remaining tumor; * ECOG performance status of \<=1.
Exclusion criteria
* previous therapy for currently treated colon cancer; * any evidence of metastatic disease; * history of other malignancy within last 5 years; * clinically significant cardiac disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE | Up to 25 weeks (from Baseline to the end of safety follow-up) | The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as \[number of participants with event divided by number analyzed\] multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE | Up to 25 weeks (from Baseline to the end of safety follow-up) | The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as \[number of participants with event divided by number analyzed\] multiplied by 100. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Capecitabine Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m\^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m\^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity. | 228 |
| Total | 228 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 19 |
| Overall Study | Disease Progression | 13 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Personal Reasons | 22 |
| Overall Study | Protocol Violation | 16 |
Baseline characteristics
| Characteristic | Capecitabine |
|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 125 Participants |
| Sex: Female, Male Male | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 81 / 228 |
| serious Total, serious adverse events | 14 / 228 |
Outcome results
Primary
Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as \[number of participants with event divided by number analyzed\] multiplied by 100.
Time frame: Up to 25 weeks (from Baseline to the end of safety follow-up)
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Capecitabine | Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE | Any AE | 56.1 percentage of participants |
| Capecitabine | Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE | Serious AE | 6.1 percentage of participants |
| Capecitabine | Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE | Death due to an AE | 0.4 percentage of participants |
Secondary
Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as \[number of participants with event divided by number analyzed\] multiplied by 100.
Time frame: Up to 25 weeks (from Baseline to the end of safety follow-up)
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Capecitabine | Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE | Early withdrawal due to an AE | 8.3 percentage of participants |
| Capecitabine | Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE | Discontinuation due to an AE | 10.1 percentage of participants |