A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label Study of the Effect of Xeloda and Radiotherapy on Pathological Response Rate in Patients With Locally Advanced Rectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Radiation: Standard radiotherapy
* Drug: Capecitabine [Xeloda]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine<br>Capecitabine orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. | Radiation: Standard radiotherapy<br>* Administered as prescribed according to normal clinical practice.<br>Drug: Capecitabine [Xeloda]<br>* 825 milligrams per meter square (mg/m^2) orally twice daily for 5 weeks.<br>* Other names: Xeloda®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 11 weeks (assessed at the time of post-treatment surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy) | 
| 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. | Up to 15 weeks (assessed 1 month after surgery) | 
| 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. | Up to 15 weeks |