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

This study has been completed.
Information provided by:
University Hospital, Ghent Identifier:
First received: February 1, 2006
Last updated: December 19, 2007
Last verified: December 2007
A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer

Condition Intervention Phase
Advanced Colorectal Cancer
Drug: Administration of high dose simplified folfiri
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Response rate

Secondary Outcome Measures:
  • Resectability
  • Safety
  • TTP

Estimated Enrollment: 106
Study Start Date: June 2004
Study Completion Date: December 2005

Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00286000

University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Principal Investigator: Marc Peeters, MD, PhD University Hospital, Ghent
  More Information

Additional Information: Identifier: NCT00286000     History of Changes
Other Study ID Numbers: 2004/195
Study First Received: February 1, 2006
Last Updated: December 19, 2007

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases processed this record on April 27, 2017