Trial information
A Study of Xeloda (Capecitabine) in Combination Chemotherapy With Eloxatin (Oxaliplatin) Plus Pelvic Irradiation Before Surgery for Rectal Cancer
Status: Completed
Protocol number: ML18280
Sponsor: Roche Pharma (Schweiz) AG; Sanofi-Synthélabo (Schweiz) AG
Company division: Pharmaceutical
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: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: capecitabine[Xeloda]
Primary outcome: 1. Pathological complete response rate
Key secondary outcomes: 1. 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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/31/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Switzerland
- Basel
- Chur
- Luzern
- St Gallen
- Zürich
