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

Advanced Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286000
• Other study ID #: 2004/195
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2006
• Last updated: December 19, 2007
• Start date: June 2004
• Est. completion date: December 2005

Study information

• Verified date: December 2007
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Administration of high dose simplified folfiri

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate
Secondary	Resectability
Secondary	Safety
Secondary	TTP

External Links

•   Website University Hospital Ghent