High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer

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: NCT00004150
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 6, 2013
European Organisation for Research and Treatment of Cancer - EORTC
Federation Francophone de Cancerologie Digestive
Grupo Espanol Tratamiento Tumores Digestivos
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for colon cancer.

PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy Phase 3

Detailed Description:


  • Compare recurrence-free survival and duration of survival in patients with stage III adenocarcinoma of the colon treated with adjuvant high-dose fluorouracil with or without leucovorin calcium versus standard fluorouracil with leucovorin calcium following curative radical resection.
  • Compare the safety of these regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to regional lymph node involvement (N1 (1-3 pericolic lymph nodes) vs N2 (more than 3 pericolic lymph nodes) and participating center.

Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive leucovorin calcium IV followed by fluorouracil IV on days 1-5. Treatment repeats every 4 weeks for 6 courses.
  • Arm II: Patients receive high-dose fluorouracil IV continuously over 48 hours weekly for 8 weeks. Treatment repeats every 8 weeks for 3 courses.


  • Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 24 hours weekly for 6 weeks. Treatment repeats every 7 weeks for 3 courses.


  • Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV bolus and then fluorouracil IV continuously over 22 hours on days 1 and 2. Treatment repeats every 2 weeks for 12 courses.

Patients are followed at 1 month, every 6 months for 4.5 years, and then annually thereafter until death.

PROJECTED ACCRUAL: Approximately 1,600 patients (800 per treatment arm) will be accrued for this study within 3 years.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Pan-European Trials in Adjuvant Colon Cancer (PETACC-2): Randomized Phase III Intergroup Trial of High-Dose Infusional 5-FU (+ or - Folinic Acid) Versus Standard Bolus 5-FU/Folinic Acid
Study Start Date : March 1999
Actual Study Completion Date : April 2007

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


  • Histologically confirmed stage III adenocarcinoma or mucinous adenocarcinoma of the colon
  • Must have had curative radical resection within 56 days prior to study

    • No local tumor therapy (i.e., polypectomy, local excision or limited intestinal resection)



  • 18 and over

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 10.0 g/dL


  • Bilirubin no greater than 2.0 mg/dL


  • Creatinine no greater than 1.5 mg/dL


  • No severe coronary heart disease
  • No New York Heart Association class III or IV heart failure


  • No other malignancy within the past 10 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
  • No uncontrolled infection
  • No other severe disease
  • No known allergy to leucovorin calcium
  • No known familial adenomatous polyposis, Crohn's disease, or ulcerative colitis
  • No hereditary syndrome (e.g., Gardner's syndrome, Turcot's syndrome, hereditary nonpolyposis colon cancer)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after study participation


Biologic therapy:

  • Not specified


  • No prior chemotherapy for colon cancer

Endocrine therapy:

  • Not specified


  • No prior radiotherapy for colon cancer


  • See Disease Characteristics


  • No other concurrent systemic anticancer therapy

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): NCT00004150

  Show 85 Study Locations
Sponsors and Collaborators
Robert Roessle Klinik
European Organisation for Research and Treatment of Cancer - EORTC
Federation Francophone de Cancerologie Digestive
Grupo Espanol Tratamiento Tumores Digestivos
OverallOfficial: Claus-Henning Koehne, MD Klinikum Oldenburg
OverallOfficial: G. Leam Saint Laurentius Ziekenhuis
OverallOfficial: Laurent Bedenne, MD Hopital Du Bocage
Study Chair: Alfredo Carrato-Mena, MD Hospital Universitario de Elche

Publications of Results:
Carrato A, Köhne C, Bedenne L, et al.: Folinic acid modulated bolus 5-FU or infusional 5-FU for adjuvant treatment of patients of UICC stage III colon cancer: preliminary analysis of the PETACC-2-study. [Abstract] J Clin Oncol 24 (Suppl 18): A-3563, 2006.

Other Publications: Identifier: NCT00004150     History of Changes
Other Study ID Numbers: CDR0000067383
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: February 2001

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer
adenocarcinoma of the colon
mucinous adenocarcinoma of the colon

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents