Trial information
A Study of Xeloda (Capecitabine) Combined With Standard Radiotherapy in Patients With Locally Advanced Rectal Cancer
Status: Completed
Protocol number: M66051
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: A study to assess the effect of pre-operative capecitabine (Xeloda) combined with standard radiotherapy on clinical response rate in patients with locally advanced rectal cancer
Brief summary: This study will evaluate the efficacy and safety of Xeloda in patients with locally advanced rectal cancer. Before surgery for rectal cancer, patients will receive daily oral Xeloda plus radiation therapy for up to 28 days. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Target sample size is 80.
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. Clinical response rate
Key secondary outcomes: 1. Safety, complete pathological remission, and relapse-free and overall survival.
Inclusion criteria:
- adult patients 18-80 years of age;
- rectal adenocarcinoma;
- rectal cancer surgery candidate, considered to benefit from pre-operative combined chemoradiotherapy.
Exclusion criteria:
- prior radiotherapy to the pelvic area or chemotherapy for colorectal cancer;
- distant metastases (resectable liver metastasis only);
- history of another malignancy within last 5 years, except cured basal cell cancer of the skin and cancer in situ of the uterine cervix.
Gender: Males or Females
Age limits: Min: 18 Years Max: 80 Years
Accepts healthy volunteers: No
Trial registration date: 03/10/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Germany
