Molecular Markers of Prognosis in Colorectal Cancer Patients

To correlate the molecular profile of a series of defined CRCs with prognosis and toxicity.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The GI unit Royal Marsden Hospital NHS trust (RMHNHST) has co-ordinated and published results from a large multicentre randomised clinical trial of patients with locally advanced CRC (Saini et al. 2003). A total of 716 patients Dukes' B and C CRC operated with curative intent were randomised to receive either bolus or infusional 5FU regimes. Patients treated at the RMHNHST made up the majority of the total sample cohort (n=550). Analysis of results after a median of 19.8 months follow-up showed that infused 5-FU given over 12 weeks resulted in similar survival to bolus 5-FU and FA over a six-month period (log rank p=0.764). There was, however, significantly less toxicity associated with the infusional regime.

Description

Inclusion Criteria:

• All patients participating in the RMHNHST study of infusional versus bolus 5FU (Saini et al. 2003).

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Investigators: Principal Investigator: David Cunningham, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: November 1, 2003

Study Registration Dates

• First Submitted: September 20, 2005
• First Submitted That Met QC Criteria: September 20, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): May 31, 2013
• Last Update Submitted That Met QC Criteria: May 30, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2348