Trial information
SOCRATES Study - A Study of Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer
Status: No longer recruiting
Protocol number: M66007
Sponsor: Roche Products Ltd.
Company division: Pharmaceutical
Official Scientific Title: An open-label study to evaluate the optimal dose of Xeloda when combined with Eloxatin and pre-operative pelvic irradiation in patients with locally advanced rectal cancer
Brief summary: This study will evaluate the optimal dose of oral Xeloda when combined with intravenous Eloxatin and preoperative radiotherapy in patients with locally advanced rectal cancer. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Target sample size is 52.
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. Objective response rate assessed by tumor measurements after completion of chemo-radiation
Key secondary outcomes: 1. Efficacy: For patients undergoing surgery, resectability rate, histopathological complete response rate, local recurrence at 36 months Safety: Adverse events, laboratory tests, performance status
Inclusion criteria:
- adult patients with 18-75 years of age;
- inoperable or locally advanced rectal cancer;
- ECOG status <=1;
- preoperative chemoradiation indicated.
Exclusion criteria:
- evidence of distant metastases;
- pre-existing condition which would deter radiotherapy ie fistulas, severe ulcerative colitis, Crohn's disease, prior adhesions;
- previous chemotherapy or radiotherapy to the pelvis;
- serious uncontrolled infection;
- history of another malignancy within last 5 years, except successfully treated basal cell cancer of skin or carcinoma in situ of uterine cervix;
- moderate or severe renal impairment.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: January, 2001
Trial registration date: 08/31/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
United Kingdom
- Aberdeen
- Bristol
- Cardiff
- Glasgow
- Leeds
- Northwood
