Patients Preference for Oral or i.v. Therapy
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Capecitabine
Fluorouracil + folinic acid
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Patients preference, Colorectal cancer, Capecitabine, Fluorouracil + folinic acid, Cross-over study
Eligibility Criteria
Inclusion Criteria: Indication for treatment with a FU-regime WHO Performance Status 0-1 Life expectancy > 3 months Adequate haematological, renal and hepatic functions Adequate contraceptives Written informed consent Exclusion Criteria: Known CNS-metastases Prior treatment with chemotherapy Pregnant or breast feeding women Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis other serious illness or medical conditions
Sites / Locations
- Department of Oncology, Esbjerg Hospital
- Department of Oncology, Odense University Hospital
- Department of Oncology, Sonderborg Hospital
- Department of Oncology, Vejle Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00212589
First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00212589
Brief Title
Patients Preference for Oral or i.v. Therapy
Official Title
A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil + Folinic Acid (Nordic FU/FA Regimen) for Patient Preference in Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2004
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Odense University Hospital
4. Oversight
5. Study Description
Brief Summary
Until recently, bolus 5-flourouracil (FU) + folinic acid (FA) has been considered the standard chemotherapy for patients with colorectal cancer. Several studies have shown that Capecitabine is as effective as Mayo regimen. The Nordic FU/FA schedule was developed to be an active and tolerable bolus regimen. The Nordic regimen consists of a short (3 minutes) bolus injection of FU and 30 minutes later FA for 2 consecutive days each 2 weeks. In randomized studies efficacy is comparable to other FU/FA regimens.
It is claimed that patients prefer oral therapy and in a randomized study comparing oral therapy (UFT/FA) and bolus FU/FA (Mayo) 84% preferred oral therapy.
In the present randomized cross-over study patients were randomized for 3 courses of Nordic FU/FA followed by 2 courses of Capecitabine (or vice versa), and patients were asked for their preference.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Patients preference, Colorectal cancer, Capecitabine, Fluorouracil + folinic acid, Cross-over study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Type
Drug
Intervention Name(s)
Fluorouracil + folinic acid
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Indication for treatment with a FU-regime
WHO Performance Status 0-1
Life expectancy > 3 months
Adequate haematological, renal and hepatic functions
Adequate contraceptives
Written informed consent
Exclusion Criteria:
Known CNS-metastases
Prior treatment with chemotherapy
Pregnant or breast feeding women
Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis
other serious illness or medical conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Pfeiffer, MD
Organizational Affiliation
Department of Oncology, Odense University Hospital, DK-5000 Odense C, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Esbjerg Hospital
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Department of Oncology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Department of Oncology, Sonderborg Hospital
City
Sonderborg
ZIP/Postal Code
6400
Country
Denmark
Facility Name
Department of Oncology, Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
15842464
Citation
Lima AP, del Giglio A. Randomized crossover trial of intravenous 5-FU versus oral UFT both modulated by leucovorin: a one-centre experience. Eur J Cancer Care (Engl). 2005 May;14(2):151-4. doi: 10.1111/j.1365-2354.2005.00531.x.
Results Reference
background
PubMed Identifier
11818199
Citation
Borner MM, Schoffski P, de Wit R, Caponigro F, Comella G, Sulkes A, Greim G, Peters GJ, van der Born K, Wanders J, de Boer RF, Martin C, Fumoleau P. Patient preference and pharmacokinetics of oral modulated UFT versus intravenous fluorouracil and leucovorin: a randomised crossover trial in advanced colorectal cancer. Eur J Cancer. 2002 Feb;38(3):349-58. doi: 10.1016/s0959-8049(01)00371-9.
Results Reference
background
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Patients Preference for Oral or i.v. Therapy
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