Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer
NCT ID: NCT00005979
Last Updated: 2021-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1998-07-22
2007-09-01
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer.
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Detailed Description
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* Compare the effect of leucovorin calcium and fluorouracil with or without irinotecan on the 3 year survival rate and overall survival of patients with resected node positive colon cancer at high risk of recurrence.
* Compare toxicities of these regimens in these patients.
* Compare quality of life of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, disease type (occlusion vs perforation vs N2 only), delay between surgery and chemotherapy (28 days or less vs over 28 days), and age (under 65 vs 65 and over). Patients are randomized to one of two treatment arms.
* Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2.
* Arm II: Patients receive irinotecan IV over 90 minutes on day 1 followed by leucovorin calcium and fluorouracil as in arm I.
Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed before treatment, after 6 and 12 courses, and then at 1 year.
Patients are followed every 3 months for 2 years, then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study within 3 years.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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FOLFIRI regimen
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Eligibility Criteria
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Inclusion Criteria
* Histologically proven stage III adenocarcinoma of the colon that has been curatively resected within past 42 days
* No metastatic disease
* Node positive
* No more than 4 nodes affected (Tx, N2, M0) AND/OR
* N1 or N2 with perforation and/or occlusion
* No prior rectal cancer within 10 cm of anal margin or that was treated with preoperative radiotherapy
* No prior inflammatory disease of the intestine
PATIENT CHARACTERISTICS:
Age:
* 18 to 75
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Neutrophil count at least 2,000/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin less than 1.25 times upper limit of normal (ULN)
* SGOT and SGPT less than 3 times ULN
* Alkaline phosphatase less than 3 times ULN
Renal:
* Not specified
Cardiovascular:
* No myocardial infarction within past 6 months
* No insufficient cardiac function
Other:
* No other serious medical illness
* No active infection
* No other malignancy except skin cancer or carcinoma in situ of the cervix
* No psychological or social condition that would preclude study
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
Surgery:
* See Disease Characteristics
* No prior extensive intestinal resection
18 Years
75 Years
ALL
No
Sponsors
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Federation Francophone de Cancerologie Digestive
OTHER
UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Marc Ychou, MD, PhD
Role: STUDY_CHAIR
Institut du Cancer de Montpellier - Val d'Aurelle
Jean Faivre
Role: STUDY_CHAIR
Federation Francophone de Cancerologie Digestive
Locations
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Centre Paul Papin
Angers, , France
Clinique St. Etienne
Bayonne, , France
Institut Bergonie
Bordeaux, , France
Centre Hospitalier de Fleyriat
Bourg-en-Bresse, , France
Centre Hospitalier de Bourgoin - Jallieu
Bourgoin, , France
Centre Hospitalier General
Brivé, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Faculte de Medecine
Dijon, , France
Hopital Du Bocage
Dijon, , France
Centre Hospitalier Maie Madeleine
Forbach, , France
Centre Leon Berard
Lyon, , France
Institut J. Paoli and I. Calmettes
Marseille, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , France
CHR D'Orleans - Hopital de la Source
Orléans, , France
Institut Jean Godinot
Reims, , France
St Joseph's Medical Center
Reims, , France
Centre Hospitalier Universitaire
Reims, , France
Centre Eugene Marquis
Rennes, , France
Hopital Charles Nicolle
Rouen, , France
Centre Rene Huguenin
Saint-Cloud, , France
Hopitaux Universitaire de Strasbourg
Strasbourg, , France
Centre Hospitalier de Tarbes
Tarbes, , France
Institut Claudius Regaud
Toulouse, , France
Centre Hospitalier Valence
Valence, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Centre Hospitalier P. Chubert
Vannes, , France
Centre Hospitalier Regionale de Vichy
Vichy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Ychou M, Raoul JL, Douillard JY, Gourgou-Bourgade S, Bugat R, Mineur L, Viret F, Becouarn Y, Bouche O, Gamelin E, Ducreux M, Conroy T, Seitz JF, Bedenne L, Kramar A. A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802). Ann Oncol. 2009 Apr;20(4):674-80. doi: 10.1093/annonc/mdn680. Epub 2009 Jan 29.
Cote JF, Kirzin S, Kramar A, Mosnier JF, Diebold MD, Soubeyran I, Thirouard AS, Selves J, Laurent-Puig P, Ychou M. UGT1A1 polymorphism can predict hematologic toxicity in patients treated with irinotecan. Clin Cancer Res. 2007 Jun 1;13(11):3269-75. doi: 10.1158/1078-0432.CCR-06-2290. Epub 2007 May 17.
Other Identifiers
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FRE-FNCLCC-ACCORD-2
Identifier Type: -
Identifier Source: secondary_id
FFCD-9802
Identifier Type: -
Identifier Source: secondary_id
EU-20014
Identifier Type: -
Identifier Source: secondary_id
CDR0000067967
Identifier Type: -
Identifier Source: org_study_id
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