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Molecular Markers of Prognosis in Colorectal Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor David Cunningham, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220142
First received: September 20, 2005
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Molecular Markers of Prognosis in Colorectal Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal Marsden NHS Foundation Trust:

Enrollment: 103
Study Start Date: November 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • All patients participating in the RMHNHST study of infusional versus bolus 5FU (Saini et al. 2003).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220142

Locations
United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Professor David Cunningham
Investigators
Principal Investigator: David Cunningham Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Professor David Cunningham, Head GI & Lymphoma Units, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00220142     History of Changes
Other Study ID Numbers: 2348
Study First Received: September 20, 2005
Last Updated: September 19, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013