Abstract
The standard adjuvant treatment for stage III colon cancer in Europe is the 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX-4) regimen, given for 6 months. Cetuximab, a monoclonal antibody directed against the EGF receptor, appears to be effective and safe when combined with oxaliplatin-based regimens, including FOLFOX-4, in patients with metastatic colorectal cancer. PETACC-8, a randomized, multicenter, European Phase III trial, is comparing the efficacy of cetuximab plus FOLFOX-4 with that of FOLFOX-4 alone in patients with stage III colon cancer. The study began in December 2005 and approximately 2000 patients are to be enrolled in nine European countries. The primary end point is disease-free survival time, analyzed after a minimum follow-up of 3 years per patient. Secondary end points include overall survival, treatment compliance, safety and pharmacogenomic parameters.
Publication types
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Clinical Trial, Phase III
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
MeSH terms
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Antibodies, Monoclonal / administration & dosage*
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Antibodies, Monoclonal, Humanized
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Cetuximab
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Chemotherapy, Adjuvant
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Colectomy / methods
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Colonic Neoplasms / drug therapy*
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Colonic Neoplasms / mortality
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Colonic Neoplasms / pathology
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Colonic Neoplasms / surgery
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Disease-Free Survival
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Europe
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Female
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Fluorouracil / administration & dosage
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Humans
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Leucovorin / administration & dosage
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Male
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Neoplasm Invasiveness / pathology
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Neoplasm Staging
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Organoplatinum Compounds / administration & dosage
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Prognosis
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Survival Analysis
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Treatment Outcome
Substances
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Antibodies, Monoclonal
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Antibodies, Monoclonal, Humanized
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Organoplatinum Compounds
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Cetuximab
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Leucovorin
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Fluorouracil