Back to resultsA Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Slovakia
Study Type
Interventional
Intervention
Standard radiotherapy
Capecitabine [Xeloda]
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Capecitabine
Arm Description
Capecitabine orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00796718
Brief Title
A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer
Official Title
An Open Label Study of the Effect of Xeloda and Radiotherapy on Pathological Response Rate in Patients With Locally Advanced Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine
Arm Type
Experimental
Arm Description
Capecitabine orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment.
Intervention Type
Radiation
Intervention Name(s)
Standard radiotherapy
Intervention Description
Administered as prescribed according to normal clinical practice.
Intervention Type
Drug
Intervention Name(s)
Capecitabine [Xeloda]
Other Intervention Name(s)
Xeloda®
Intervention Description
825 milligrams per meter square (mg/m^2) orally twice daily for 5 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants With Pathological Complete Response
Description
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)
Secondary Outcome Measure Information:
Title
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)
Description
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)
Title
Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)
Description
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)
Title
Percentage of Participants With Adverse Events
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
12. IPD Sharing Statement
Learn more about this trial
A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer
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