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Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: September 7, 2004
Last updated: February 6, 2009
Last verified: December 2006

RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known whether combination chemotherapy is more effective than observation alone in treating patients who have undergone surgery for colon cancer.

PURPOSE: This randomized phase III trial is studying irinotecan and fluorouracil with or without leucovorin to see how well they work compared to observation alone in treating patients who have undergone surgery for stage II colon cancer.

Condition Intervention Phase
Colorectal Cancer
Drug: FOLFIRI regimen
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase III Intergroup Trial in Resected Stage 2 (Dukes B) Colon Cancer: 6-Month Infusional 5FU-CPT11 (+/- Folinic Acid) Versus Observation - Determination of Biologic Predictive and Response Factors

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival at 5 years

Secondary Outcome Measures:
  • Overall survival at 8 years
  • Tolerability
  • Correlation of clinical, histological, and biological prognostic factors with outcome

Estimated Enrollment: 1976
Study Start Date: June 2004
Detailed Description:



  • Compare 5-year disease-free survival in patients with resected stage II adenocarcinoma of the colon treated with adjuvant chemotherapy comprising fluorouracil and irinotecan with or without leucovorin calcium vs no adjuvant therapy.


  • Compare 8-year overall survival in patients treated with these regimens.
  • Compare tolerability of these regimens in these patients.
  • Correlate clinical, histological, and biological prognostic factors with outcome in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease stage (pT3 vs pT4), pathological differentiation (poorly or undifferentiated vs well or moderately differentiated), and microsatellite instability (positive vs negative vs unknown). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients are further randomized to receive 1 of 3 adjuvant chemotherapy regimens.

    • Regimen A: Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1, 15, and 29. Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
    • Regimen B: Patients receive irinotecan IV over 30-90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 24 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
    • Regimen C: Patients receive irinotecan IV over 60 minutes followed by fluorouracil IV continuously over 48 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo observation only. Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 1,976 patients (988 per treatment arm [247 each in regimens A and B of arm I and 494 in regimen C of arm I]) will be accrued for this study within 4.5 years.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the colon

    • Stage II disease (pT3, N0 or pT4, N0)

      • Penetration of the subserosa or serosa
      • No lymph node metastases

        • At least 12 lymph nodes analyzed
  • More than 1 synchronous primary colon tumor allowed

    • Staging determined for the more advanced tumor
  • Curative radical resection within the past 2-8 weeks required

    • Proximal, distal, and radical margins must be free of tumor (R0 resection)
  • No rectal tumors

    • Gross distal margin of the primary tumor must lie above the peritoneal reflection
  • No known familial adenomatous polyposis
  • No hereditary nonpolyposis colorectal cancer
  • No distant metastases



  • 18 to 75

Performance status

  • WHO 0-1

Life expectancy

  • Not specified


  • Granulocyte count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000mm^3
  • Hemoglobin ≥ 10 g/dL


  • Bilirubin < 1.25 times upper limit of normal (ULN)
  • No known Gilbert's syndrome


  • Creatinine < 1.25 times ULN


  • No severe or uncontrolled coronary disease
  • No severe heart failure
  • No uncontrolled arterial hypertension
  • No myocardial infarction within the past year
  • No cerebral vascular accident within the past year
  • Cardiac arrhythmia allowed provided patient is on proper anticoagulation therapy* NOTE: *Aspirin is not considered proper anticoagulation


  • No Gardner's syndrome
  • No Turcot's syndrome
  • No Crohn's disease
  • No ulcerative colitis


  • No other prior malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
  • No other serious disease
  • No contraindication to any study drugs
  • No known allergy to leucovorin calcium
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 6 months after study treatment


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy


  • See Disease Characteristics


  • No other concurrent anticancer therapy
  • No concurrent vitamin supplements containing folic acid
  Contacts and Locations
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Please refer to this study by its identifier: NCT00091312

National Cancer Institute - Cairo
Cairo, Egypt
Centre Hospitalier Universitaire Ambroise Pare - Boulogne
Boulogne Billancourt, France, F-92104
Hopital Du Bocage
Dijon, France, 21034
Medizinische Klinik I
Dresden, Germany, D-01307
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100
Azienda Ospedaliero Careggi
Florence, Italy, 50139
Universita Degli Studi di Florence - Policlinico di Careggi
Florence, Italy, 50139
Instituto Portugues de Oncologia Centro do Porto, S. A.
Porto, Portugal, 4200-072
Hospital Universitario de Elche
Elche Alicante, Spain, E-03203
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Study Chair: Laurent Bedenne, MD Hopital Du Bocage
  More Information Identifier: NCT00091312     History of Changes
Other Study ID Numbers: CDR0000387797
Study First Received: September 7, 2004
Last Updated: February 6, 2009

Keywords provided by National Cancer Institute (NCI):
stage II colon cancer
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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents processed this record on April 28, 2017