Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2002-12-31
2004-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
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Capecitabine
Fluorouracil + folinic acid
Eligibility Criteria
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Inclusion Criteria
* WHO Performance Status 0-1
* Life expectancy \> 3 months
* Adequate haematological, renal and hepatic functions
* Adequate contraceptives
* Written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Principal Investigators
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Per Pfeiffer, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Oncology, Odense University Hospital, DK-5000 Odense C, Denmark
Locations
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Department of Oncology, Esbjerg Hospital
Esbjerg, , Denmark
Department of Oncology, Odense University Hospital
Odense, , Denmark
Department of Oncology, Sonderborg Hospital
Sønderborg, , Denmark
Department of Oncology, Vejle Hospital
Vejle, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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11.02
Identifier Type: -
Identifier Source: org_study_id