Patients Preference for Oral or i.v. Therapy

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00212589
First received: September 13, 2005
Last updated: NA
Last verified: May 2004
History: No changes posted
  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-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: Denmark: Danish Medicines Agency

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
Fluorouracil
Capecitabine
Leucovorin
Folic Acid
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes

ClinicalTrials.gov processed this record on July 20, 2014