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A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil + Folinic Acid (Nordic FU/FA Regimen) for Patient Preference in Colorectal Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil + Folinic Acid (Nordic FU/FA Regimen) for Patient Preference in Colorectal Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Per Pfeiffer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, Odense University Hospital, DK-5000 Odense C, Denmark

Authority:

Denmark: Danish Medicines Agency

Study ID:

11.02

NCT ID:

NCT00212589

Start Date:

December 2002

Completion Date:

April 2004

Related Keywords:

  • Colorectal Cancer
  • Patients preference
  • Colorectal cancer
  • Capecitabine
  • Fluorouracil + folinic acid
  • Cross-over study
  • Colorectal Neoplasms

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