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Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer Clinical research trials and Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer. Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer  Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer
Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer
For Condition: adenocarcinoma of the colon,stage 3 colon cancer
Status: No longer recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer , Federation Francophone de Cancerologie Digestive
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarcYchou, Study Chair, Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Hopital Charles Nicolle
Rouen, , 76031
France
Centre Leon Berard
Lyon, , 69008
France
Centre Hospitalier P. Chubert
Vannes, , 56260
France
St Joseph's Medical Center
Reims, , 51056
France
Centre Hospitalier Maie Madeleine
Forbach, , 57600
France
Hopitaux Universitaire de Strasbourg
Strasbourg, , 67091
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , 34298
France
Institut Bergonie
Bordeaux, , 33076
France
Centre Regional Francois Baclesse
Caen, , 14076
France
Clinique St. Etienne
Bayonne, , 64100
France
Centre Hospitalier Regionale de Vichy
Vichy, , 03201
France
Centre Hospitalier Universitaire
Reims, , 51092
France
Centre Rene Huguenin
Saint Cloud, , 92210
France
CHR D'Orleans - Hopital de la Source
Orleans, , 45067
France
Centre Eugene Marquis
Rennes, , 35064
France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Institut J. Paoli and I. Calmettes
Marseille, , 13273
France
Institut Jean Godinot
Reims, , 51056
France
Centre Hospitalier Valence
Valence, , 26000
France
Hopital Du Bocage
Dijon, , 21034
France
Centre Hospitalier General
Brive, , 19101
France
Centre Hospitalier Universitaire Henri Mondor
Creteil, , 94010
France
Institut Claudius Regaud
Toulouse, , 31052
France
Centre Hospitalier de Fleyriat
Bourg-en-Bresse, , 01012
France
Centre Paul Papin
Angers, , 49036
France
Institut Gustave Roussy
Villejuif, , F-94805
France
Centre Hospitalier de Bourgoin - Jallieu
Bourgoin-Jallieu, , 38300
France
Centre Hospitalier de Tarbes
Tarbes, , 65013
France
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, , 54511
France
Faculte de Medecine
Dijon, , 21033
France
Additional Information:
Study ID Numbers: CDR0000067967; EU-20014,FRE-FNCLCC-ACCORD-2,FFCD-9802
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005979
Other Stage 3 Colon Cancer Studies:
1. Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed
2. Comparison of Adjuvant Combination Chemotherapy Regimens in Treating Patients With Resected Stage III Colon Cancer
3. High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
4. Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer
5. Combination Chemotherapy in Treating Patients With Colorectal Cancer
Related Studies:
Other stage 3 colon cancer Clinical Trials
Other Clinical Trials
Other Brive Clinical Trials
Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer
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