Roche trials database

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

Co-sponsors:

• 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

Conditions:

• 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

Anticipated start date:

March, 2005

Trial registration date:

21.12.2005

Date last updated:

22.01.2010

This trial was conducted at the following locations:

Switzerland

• BASEL
• CHUR
• LUZERN
• ST. GALLEN
• ZÜRICH

Link to trial result