NCT00220142

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

First QC Date

September 20, 2005

Last Update Submit

May 30, 2013

Conditions

Colorectal Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • David Cunningham

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

November 1, 2003

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

GB(1)