Trial information
A Study of Xeloda (Capecitabine) plus Radiotherapy in Patients With Locally Advanced Rectal Cancer
Status: Recruiting
Protocol number: ML21800
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study of the effect of Xeloda and radiotherapy on pathological response rate in patients with locally advanced rectal cancer.
Brief summary: This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in patients with locally advanced rectal cancer. Eligible patients will receive Xeloda 825mg/m2 po bid 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. Target sample size is 44.
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 Time frame: 4 weeks after end of treatment
Key secondary outcomes: 1. Adverse events, laboratory parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-80 years of age
- rectal cancer;
- planned surgery, and likely to benefit from pre=operative combined chemo-radiotherapy;
- 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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 80 Years
Accepts healthy volunteers: No
Trial registration date: 11/21/2008
Date last updated: 12/19/2008
Link to trial result
This trial is being conducted at the following locations:
Slovakia
