High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study

Phase 2

Completed

• Conditions: Advanced Colorectal Cancer

• Registration Number: NCT00286000
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study Completion: 2005-12
• Study First Submitted: 2006-02-01
• Study First Submitted QC: 2006-02-01
• Study First Posted: 2006-02-02
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate

Secondary Outcome Measures

Name	Time	Method
Resectability
Safety
TTP

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium