NCT00286000

Brief Summary

A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_2

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

June 1, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

February 1, 2006

Last Update Submit

December 19, 2007

Conditions

Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate

Secondary Outcomes (3)

  • Resectability

  • Safety

  • TTP

Interventions

Administration of high dose simplified folfiriDRUG

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Active uncontrolled infection
  • Other concomitant anticancer agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

Study Officials

  • Marc Peeters, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 2, 2006

Study Start

June 1, 2004

Study Completion

December 1, 2005

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

BE(1)