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Status:

UNKNOWN

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

Lead Sponsor:

Federation Francophone de Cancerologie Digestive

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

Brief Summary

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 d...

Detailed Description

OBJECTIVES: Primary * Compare 5-year disease-free survival in patients with resected stage II adenocarcinoma of the colon treated with adjuvant chemotherapy comprising fluorouracil and irinotecan wi...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 to 75
  • Performance status
  • WHO 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Granulocyte count ≥ 2,000/mm\^3
  • Platelet count ≥ 100,000mm\^3
  • Hemoglobin ≥ 10 g/dL
  • Hepatic
  • Bilirubin \< 1.25 times upper limit of normal (ULN)
  • No known Gilbert's syndrome
  • Renal
  • Creatinine \< 1.25 times ULN
  • Cardiovascular
  • 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
  • Gastrointestinal
  • No Gardner's syndrome
  • No Turcot's syndrome
  • No Crohn's disease
  • No ulcerative colitis
  • Other
  • 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
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • No prior chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • No prior radiotherapy
  • Surgery
  • See Disease Characteristics
  • Other
  • No other concurrent anticancer therapy
  • No concurrent vitamin supplements containing folic acid

Exclusion

    Key Trial Info

    Start Date :

    June 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    1976 Patients enrolled

    Trial Details

    Trial ID

    NCT00091312

    Start Date

    June 1 2004

    Last Update

    February 9 2009

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    National Cancer Institute - Cairo

    Cairo, Egypt

    2

    Centre Hospitalier Universitaire Ambroise Pare - Boulogne

    Boulogne-Billancourt, France, F-92104

    3

    Hopital Du Bocage

    Dijon, France, 21034

    4

    Medizinische Klinik I

    Dresden, Germany, D-01307