Administration of high dose simplified folfiri in Advanced Colorectal Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Advanced Colorectal Cancer

Intervention / Treatment

Drug: Administration of high dose simplified folfiri

Study Type

Interventional

Enrollment

106

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Ghent, Belgium, 9000
    - University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologically or cytologically proven adenocarcinoma of the colon or rectum
Documented progressive metastatic disease
Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to response evaluation criteria in solid tumours (RECIST)
WHO performance status of 0 or 1
Adequate laboratory values of haematology, liverfunction and renal function
No previous chemotherapy for metastatic colorectal cancer

Exclusion Criteria:

Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated cancer free of disease for more than 10 years.
Bowel obstruction or sub-obstruction. Crohn's disease, or ulcerative colitis.
Other severe illness or medical condition such as unstable cardiac disease under treatment, myocardial infarction within 6 months before inclusion.
Active uncontrolled infection
Other concomitant anticancer agent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate

Secondary Outcome Measures

Outcome Measure
Safety
Resectability
TTP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

Principal Investigator: Marc Peeters, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

website University Hospital Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

February 1, 2006

First Submitted That Met QC Criteria