Back to resultsA Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 4
Locations
Bulgaria
Study Type
Interventional
Intervention
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Adults at least 18 years of age
- Curative surgery for Stage III colon cancer, performed 4 to 8 weeks before study entry
Exclusion Criteria:
- Macroscopic or microscopic residual tumor
- Evidence of metastatic disease including tumor cells in ascites
- Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer
- Active cardiovascular disease
- Other malignancy within the last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix
- Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Capecitabine
Arm Description
Participants will receive capecitabine for up to approximately 6 months.
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs)
Incidence of treatment discontinuation due to AEs
Secondary Outcome Measures
Incidence of toxocity-related dose reductions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02581423
Brief Title
A Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer
Official Title
Phase IV Clinical Study of Safety and Tolerability of Oral Xeloda (Capecitabine) in Adjuvant Treatment of Resected Cancer of the Colon
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (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 study will evaluate the safety and tolerability of capecitabine (Xeloda) in participants who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily in 3-week cycles for a total of up to 8 cycles. The anticipated time on study treatment is 24 weeks, and the target sample size is 70 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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine
Arm Type
Experimental
Arm Description
Participants will receive capecitabine for up to approximately 6 months.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Participants will receive oral capecitabine, 1250 miligrams per meter-squared (mg/m^2) twice daily, in 3-week treatment cycles for up to 8 cycles. Treatment will be administered for 2 weeks followed by 1 week of rest without medication.
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
Up to approximately 6 months
Title
Incidence of treatment discontinuation due to AEs
Time Frame
Up to approximately 6 months
Secondary Outcome Measure Information:
Title
Incidence of toxocity-related dose reductions
Time Frame
Up to approximately 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults at least 18 years of age
Curative surgery for Stage III colon cancer, performed 4 to 8 weeks before study entry
Exclusion Criteria:
Macroscopic or microscopic residual tumor
Evidence of metastatic disease including tumor cells in ascites
Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer
Active cardiovascular disease
Other malignancy within the last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix
Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
City
Shumen
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
12. IPD Sharing Statement
Learn more about this trial
A Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer
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