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

Phase 2
18 Years
69 Years
Not Enrolling
Advanced Colorectal Cancer

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Principal Investigator

Marc Peeters, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent


Belgium: Institutional Review Board

Study ID:




Start Date:

June 2004

Completion Date:

December 2005

Related Keywords:

  • Advanced Colorectal Cancer
  • Colorectal Neoplasms