Status:
COMPLETED
High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study
Lead Sponsor:
University Hospital, Ghent
Conditions:
Advanced Colorectal Cancer
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief Summary
A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00286000
Start Date
June 1 2004
End Date
December 1 2005
Last Update
December 28 2007
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000