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

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Radiation: Standard radiotherapy; Drug: Capecitabine [Xeloda]

• Registration Number: NCT00796718
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2016-07
• Results First Submitted: 2016-07-14
• Results First Submitted QC: 2016-07-14
• Last Update Submitted: 2016-07-14
• Results First Posted: 2016-08-25
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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Exclusion Criteria

• previous radiotherapy or chemotherapy for colorectal cancer;
• clinically significant cardiovascular disease;
• significant gastric or small intestine disease;
• serious uncontrolled active infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capecitabine	Capecitabine [Xeloda]	Capecitabine orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment.
Capecitabine	Standard radiotherapy	Capecitabine orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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.