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Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
FOLFIRI regimen
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Sponsored by
UNICANCER
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, adenocarcinoma of the colon

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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

Sites / Locations

  • Centre Paul Papin
  • Clinique St. Etienne
  • Institut Bergonie
  • Centre Hospitalier de Fleyriat
  • Centre Hospitalier de Bourgoin - Jallieu
  • Centre Hospitalier General
  • Centre Regional Francois Baclesse
  • Centre Hospitalier Universitaire Henri Mondor
  • Faculte de Medecine
  • Hopital Du Bocage
  • Centre Hospitalier Maie Madeleine
  • Centre Leon Berard
  • Institut J. Paoli and I. Calmettes
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • CRLCC Nantes - Atlantique
  • CHR D'Orleans - Hopital de la Source
  • Institut Jean Godinot
  • St Joseph's Medical Center
  • Centre Hospitalier Universitaire
  • Centre Eugene Marquis
  • Hopital Charles Nicolle
  • Centre Rene Huguenin
  • Hopitaux Universitaire de Strasbourg
  • Centre Hospitalier de Tarbes
  • Institut Claudius Regaud
  • Centre Hospitalier Valence
  • Centre Alexis Vautrin
  • Centre Hospitalier P. Chubert
  • Centre Hospitalier Regionale de Vichy
  • Institut Gustave Roussy

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
February 15, 2021
Sponsor
UNICANCER
Collaborators
Federation Francophone de Cancerologie Digestive
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1. Study Identification

Unique Protocol Identification Number
NCT00005979
Brief Title
Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer
Official Title
Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 22, 1998 (Actual)
Primary Completion Date
September 26, 2005 (Actual)
Study Completion Date
September 1, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
Collaborators
Federation Francophone de Cancerologie Digestive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer. 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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage III colon cancer, adenocarcinoma of the colon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FOLFIRI regimen
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Ychou, MD, PhD
Organizational Affiliation
Institut du Cancer de Montpellier - Val d'Aurelle
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jean Faivre
Organizational Affiliation
Federation Francophone de Cancerologie Digestive
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49036
Country
France
Facility Name
Clinique St. Etienne
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Hospitalier de Fleyriat
City
Bourg-En-Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
Centre Hospitalier de Bourgoin - Jallieu
City
Bourgoin-Jallieu
ZIP/Postal Code
38300
Country
France
Facility Name
Centre Hospitalier General
City
Brive
ZIP/Postal Code
19101
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Faculte de Medecine
City
Dijon
ZIP/Postal Code
21033
Country
France
Facility Name
Hopital Du Bocage
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Centre Hospitalier Maie Madeleine
City
Forbach
ZIP/Postal Code
57600
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
CRLCC Nantes - Atlantique
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
CHR D'Orleans - Hopital de la Source
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
St Joseph's Medical Center
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35064
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Hopitaux Universitaire de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Centre Hospitalier de Tarbes
City
Tarbes
ZIP/Postal Code
65013
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Hospitalier Valence
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Centre Hospitalier P. Chubert
City
Vannes
ZIP/Postal Code
56260
Country
France
Facility Name
Centre Hospitalier Regionale de Vichy
City
Vichy
ZIP/Postal Code
03201
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19179549
Citation
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.
Results Reference
result
PubMed Identifier
17510208
Citation
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.
Results Reference
result

Learn more about this trial

Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer

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