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Titre abrégé
Prodige 52 - Irocas
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NCT
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N° Eudract
2016-001491-29
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Phase de l'essai
- Phase III
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Type de promoteur
Académique / Institutionnel
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Nom du promoteur
Unicancer
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1.Patient e"18 years and < 71years 2.Patient with ECOG d"1 3.Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1 or pT1-4N2 tumor. 4.Curative R0 surgical resection within 42 days before randomization. 5.Patients who have undergone surgery for colon cancer, defined as a tumor location >12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (high rectum), without gross or microscopic evidence of residual disease after surgery with curative intent 6.Start of study drug treatment has to be performed less than 56 days after surgery. 7.No prior chemotherapy. 8.No prior abdominal or pelvic irradiation. 9.Patient with adequate organ function: Absolute neutrophil count (ANC) e" 2 x 109/L Haemoglobin e"9 g/dL Platelets (PTL) e"100 x 109/L AST/ALT d"2.5 x ULN Alkaline phosphatase d"2.5 x ULN Total Bilirubin d"1.5 x ULN (Upper Limit of Normal) Creatinine clearance e"50 mL/min (Cockcroft and Gault formula) Kalemia, magnesemia, calcemia e" 1 LLN (Lower Limit of Normal) Carcinoembryogenic antigen (CEA) d"10ng/mL after surgery (during screening period) 10.Adequate contraception if applicable. 11.Patient able and willing to comply with study procedures as per protocol 12.Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures 13.Public or private health insurance coverage 14.Life expectancy of > or = at 5 years
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1.Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study 2.Metastatic disease 3.Presence of inflammatory bowel disease and/or ileus 4.Known hypersensitivity reaction to any of the components of study treatments. 5.Pregnancy (absence to be confirmed by ²-hCG test) or breast-feeding period 6.Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia (for men: QT/QTc e"450 msec, for women: QT/QTc e"470 msec) 7.Previous malignancy in the last 5 years except curative treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix 8.Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent 9.History or current evidence on physical examination of central nervous system disease or peripheral neuropathy e" grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v4.03. 10.Any significant disease which, in the investigator's opinion, would exclude the patient from the study. 11.Known DPD deficiency or UGT1A1 homozygous 7/7 12.Patients already included in another therapeutic trial involving an experimental drug
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Nom du centre
CH de Valence
Valence -
Contact Investigateur
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Nom
Dr. Nicolas ETCHEPARE
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Téléphone
04-75-75-75-12
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Contact ARC/TER/IRC
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Nom
Mme Marine BAUDIN
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Téléphone
04-75-75-78-81
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Fax
04-75-75-72-80
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Email