Advanced Colorectal Cancer
Conditions
Brief summary
A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer
Interventions
DRUGAdministration of high dose simplified folfiri
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Resectability | — |
| Safety | — |
| TTP | — |
Countries
Belgium
Outcome results
None listed