Clinical Trial Protocol Registry
A Study of Xeloda (Capecitabine) in Combination Chemotherapy With Eloxatin (Oxaliplatin) Plus Pelvic Irradiation Before Surgery for Rectal Cancer
- Protocol number:
- Roche Pharma (Schweiz) AG
- Sanofi-Synthélabo (Schweiz) AG
- Company division:
- Official Scientific Title:
- An open-label study of the effect of combination chemotherapy containing Xeloda plus Eloxatin (Xelox) with pre-operative pelvic radiotherapy in patients with rectal cancer without metastases
- Brief summary:
- This study will evaluate the efficacy and safety of combination chemotherapy containing Xeloda plus Eloxatin (Xelox) with pre-operative pelvic irradiation as pre-operative treatment before surgery to remove the primary tumor. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 60.
- Study phase:
- Study type:
- Interventional; Treatment; Non-randomized; Open Label; Uncontrolled; Single group; Safety/efficacy study
- Colorectal Cancer
- Intervention type:
- Intervention name:
- capecitabine [Xeloda]
- Primary outcome:
- Pathological complete response rate
- Key secondary outcomes:
- Efficacy: Sphincter-preservation, R0 resection in patients with T4 rectal cancer, downstaging of primary tumor and/or lymph nodes, and pathological incomplete tumor response rate. Safety: Adverse events and laboratory values
- Inclusion criteria:
- adult patients >=18 years;
- advanced rectal cancer requiring surgery of the primary tumor.
- Exclusion criteria:
- evidence of distant metastases;
- chemotherapy or immunotherapy for colorectal cancer;
- previous radiotherapy to the pelvis;
- malignancy within last 5 years, except cured basal cell cancer of the skin and in situ cancer of the cervix.
- Males or Females
- Age limits:
- Min: 18 years Max: N/A (No limit)
- Accepts healthy volunteers:
- Anticipated start date:
- March, 2005
- Trial registration date:
- Date last updated:
- ST. GALLEN
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