Colorectal Cancer
Conditions
Brief summary
This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible participants will receive Xeloda 825mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated time on study treatment is \< 3 months, and the target sample size is \< 100 individuals.
Interventions
RADIATIONStandard radiotherapy
Administered as prescribed according to normal clinical practice.
DRUGCapecitabine [Xeloda]
825 milligrams per meter square (mg/m\^2) orally twice daily for 5 weeks.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* adult patients, 18-80 years of age; * rectal cancer; * planned surgery, and likely to benefit from pre-operative combined chemo-radiotherapy; * Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion criteria
* previous radiotherapy or chemotherapy for colorectal cancer; * clinically significant cardiovascular disease; * significant gastric or small intestine disease; * serious uncontrolled active infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pathological Complete Response | Up to 11 weeks (assessed at the time of post-treatment surgery) | Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment) | Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy) | Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD. |
| Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment) | Up to 15 weeks (assessed 1 month after surgery) | Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD. |
| Percentage of Participants With Adverse Events | Up to 15 weeks | An adverse event was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment. |
Countries
Slovakia
Participant flow
Pre-assignment details
A total of 62 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Capecitabine Capecitabine 825 mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment. | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Exclusion Criteria | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Informed Consent | 1 |
Baseline characteristics
| Characteristic | Capecitabine |
|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 49 / 62 |
| serious Total, serious adverse events | 4 / 62 |
Outcome results
Primary
Percentage of Participants With Pathological Complete Response
Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures.
Time frame: Up to 11 weeks (assessed at the time of post-treatment surgery)
Population: Participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine | Percentage of Participants With Pathological Complete Response | 16 percentage of participants |
Secondary
Percentage of Participants With Adverse Events
An adverse event was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 15 weeks
Population: All enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine | Percentage of Participants With Adverse Events | 91.9 percentage of participants |
Secondary
Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)
Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.
Time frame: Up to 15 weeks (assessed 1 month after surgery)
Population: Participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Capecitabine | Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment) | Complete Response | 56 percentage of participants |
| Capecitabine | Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment) | Partial Remission | 10 percentage of participants |
| Capecitabine | Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment) | No Response | 14 percentage of participants |
Secondary
Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)
Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.
Time frame: Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy)
Population: Participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Capecitabine | Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment) | Complete Response | 2 percentage of participants |
| Capecitabine | Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment) | Partial Remission | 12.2 percentage of participants |
| Capecitabine | Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment) | No Response | 77.6 percentage of participants |