High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study
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Ages Eligible for Study:
18 Years to 69 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.