Clinical Trial Protocol Registry
A Study of Xeloda (Capecitabine) in the Adjuvant Treatment of Patients With Resected Colon Cancer
- Protocol number:
- Roche Bulgaria EOOD
- Company division:
- Official Scientific Title:
- A clinical study of the safety and tolerability of oral Xeloda (capecitabine) in adjuvant treatment of resected cancer of the colon
- Brief summary:
- This study will evaluate the safety and tolerability of Xeloda in patients who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily for 8 x 3 week cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 63.
- Study phase:
- Study type:
- Interventional; Treatment; Non-randomized; Open Label; Uncontrolled; Single group; Safety study
- Colorectal Cancer
- Intervention type:
- Intervention name:
- capecitabine [Xeloda]
- Primary outcome:
- Safety:% of patients with AEs,and SAEs. Tolerability:premature withdrawals due to AEs;dose reductions due to toxicity
- Key secondary outcomes:
- Comparison of 3 different viral kinetic phases
- Inclusion criteria:
- adult patients >=18 years of age;
- curative surgery (>=4 and <=8 weeks before study) for stage III colon cancer.
- Exclusion criteria:
- macroscopic or microscopic evidence of remaining tumor;
- evidence of metastatic disease, including tumor cells in ascites;
- previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer;
- active cardiovascular disease;
- malignancy within last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix;
- lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- Males or Females
- Age limits:
- Min: 18 years Max: N/A (No limit)
- Accepts healthy volunteers:
- Anticipated start date:
- August, 2005
- Trial registration date:
- Date last updated:
- VELIKO TARNOVO
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