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
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