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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00286000
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : December 28, 2007
Information provided by:
University Hospital, Ghent

Brief Summary:
A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer

Condition or disease Intervention/treatment Phase
Advanced Colorectal Cancer Drug: Administration of high dose simplified folfiri Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study
Study Start Date : June 2004
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Response rate

Secondary Outcome Measures :
  1. Resectability
  2. Safety
  3. TTP

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00286000

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University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
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Principal Investigator: Marc Peeters, MD, PhD University Hospital, Ghent
Additional Information:
Layout table for additonal information Identifier: NCT00286000    
Other Study ID Numbers: 2004/195
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases