Trial information
A Study of Xeloda (Capecitabine) Plus Radiotherapy in Patients With Rectal Cancer
Status: Completed
Protocol number: M66011
Sponsor: Roche S.p.A. Italy
Company division: Pharmaceutical
Official Scientific Title: An open-label study of Xeloda in combination with pre-operative standard radiotherapy on pathological response in patients with rectal cancer
Brief summary: This study will evaluate the efficacy and safety of oral Xeloda in combination with standard radiotherapy before surgery in patients with rectal cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is
43.
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. Complete response rate based on pathological tumor assessment after definitive surgery within 6 weeks of completion of chemotherapy
Key secondary outcomes: 1. Safety: Adverse events and laboratory parameters.
Efficacy: Pathological tumor assessment and clinical tumor and lymph node assessment after definitive surgery within 6-8 weeks of completion of chemo-radiotherapy
Inclusion criteria:
- adult patients 18-80 years of age;
- rectal cancer;
- need for surgery.
Exclusion criteria:
- previous radiotherapy or chemotherapy for colorectal cancer;
- clinically significant cardiac disease;
- history of lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome;
- history of cancer within last 5 years, except basal cell cancer of the skin or cancer in situ of the cervix.
Gender: Males or Females
Age limits: Min: 18 Years Max: 80 Years
Accepts healthy volunteers: No
Trial registration date: 10/27/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Ancona
- Aviano
- Bergamo
- Genova
- Milano
- Modena
- Padova
