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Trial record 13 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

Patients Preference for Oral or i.v. Therapy

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: NCT00212589
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Information provided by:
Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Capecitabine Drug: Fluorouracil + folinic acid Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 2002
Study Completion Date : April 2004

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00212589

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Department of Oncology, Esbjerg Hospital
Esbjerg, Denmark, 6700
Department of Oncology, Odense University Hospital
Odense, Denmark, 5000
Department of Oncology, Sonderborg Hospital
Sonderborg, Denmark, 6400
Department of Oncology, Vejle Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Odense University Hospital
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Principal Investigator: Per Pfeiffer, MD Department of Oncology, Odense University Hospital, DK-5000 Odense C, Denmark

Layout table for additonal information Identifier: NCT00212589     History of Changes
Other Study ID Numbers: 11.02
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 21, 2005
Last Verified: May 2004
Keywords provided by Odense University Hospital:
Patients preference
Colorectal cancer
Fluorouracil + folinic acid
Cross-over study
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Folic Acid
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Growth Substances