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Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer

Last updated on February 22, 2020

Study Location
Allgemeines Krankenhaus der Stadt Wien
Vienna (Wien), , A-1090 Austria
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Cancer
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer


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Descriptive Information
Brief Title  ICMJE Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer
Official Title  ICMJE Multicenter Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone As Adjuvant Treatment Of Stage III Colon Cancer
Brief Summary

RATIONALE: Drugs used in chemotherapy use 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 more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colorectal cancer.

Detailed Description


  • Compare the disease-free survival at 3 years of patients with resected stage III colorectal cancer treated with adjuvant fluorouracil and leucovorin calcium with or without irinotecan.
  • Compare the disease-free and overall survival at 5 years of patients treated with these regimens.
  • Compare the safety profiles of these treatment regimens in these patients.
  • Compare the quality-adjusted survival of patients treated with these regimens.
  • Correlate the expression of putative prognostic markers (thymidylate synthase, telomerase, topoisomerase) with disease-free and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

Arm I

  • Patients receive irinotecan IV over 30-90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 24 hours weekly for 6 weeks. Courses repeat every 7 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  • As an alternative schedule, patients may receive irinotecan IV over 30-90 minutes and day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2 every 2 weeks for 6 weeks. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Arm II

  • Patients receive leucovorin calcium and fluorouracil as in arm I. Quality of life may be assessed at baseline; prior to courses 2, 3, and 4; and at 1, 3, and 6 months.

Patients are followed every 3 months for 3 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 1800 patients (900 per arm) will be accrued for this study within 24 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: FOLFIRI regimen
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications
identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE


  • Histologically confirmed adenocarcinoma of the colon or intraperitoneal rectum

    • Stage III
    • Completely resected within the past 3-8 weeks

      • No gross or microscopic evidence of residual disease after surgery
  • No rectal cancer requiring total meso-rectal resection or pre- or postoperative radiotherapy
  • No prior curatively resected synchronous metastasis of colorectal cancer



  • 18 to 75

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 150,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin no greater than upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min


  • No myocardial infarction with the past year
  • No uncontrolled hypertension
  • No high-risk uncontrolled arrhythmia
  • No unstable angina pectoris


  • HIV negative
  • No chronic diarrhea
  • No current chronic inflammation or subobstruction of bowel after surgery
  • No active uncontrolled infection
  • No other prior or concurrent malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No psychological, social, familial, or geographical condition that would preclude follow-up
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation


Biologic therapy:

  • Not specified


  • No prior antineoplastic chemotherapy

Endocrine therapy:

  • Not specified


  • See Disease Characteristics


  • See Disease Characteristics
  • No prior celioscopic resection of primary tumor


  • At least 30 days since prior participation in another clinical trial with any investigational drug
  • No other concurrent experimental drugs
  • No other concurrent anticancer therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Egypt,   France,   Germany,   Italy,   Portugal,   Spain,   Switzerland,   United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00026273
Other Study ID Numbers  ICMJE XRP 4174B-307
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Eric Van Cutsem, MD, PhD University Hospital, Gasthuisberg
PRS Account Pfizer
Verification Date August 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP


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