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Patients Preference for Oral or i.v. Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212589
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
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.
Information provided by:
Odense University Hospital
  Purpose

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 Intervention Phase
Colorectal Cancer Drug: Capecitabine Drug: Fluorouracil + folinic acid Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Estimated Enrollment: 60
Study Start Date: December 2002
Estimated Study Completion Date: April 2004
  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00212589


Locations
Denmark
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
Investigators
Principal Investigator: Per Pfeiffer, MD Department of Oncology, Odense University Hospital, DK-5000 Odense C, Denmark
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00212589     History of Changes
Other Study ID Numbers: 11.02
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
Last Verified: May 2004

Keywords provided by Odense University Hospital:
Patients preference
Colorectal cancer
Capecitabine
Fluorouracil + folinic acid
Cross-over study

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Fluorouracil
Leucovorin
Levoleucovorin
Folic Acid
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Hematinics