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Title:
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A Randomized Phase III Study Comparing 5-FU Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers - IRB# 06-44A
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Treatments:
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5 FU, Bevacizumab, Leucovorin, Oxaliplatin
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Disease Site:
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Gastrointestinal
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Disease SubSite:
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Colon
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Drug Provided:
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Bevacizumab, Oxaliplatin
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Comments:
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MEDICARE STUDY: Please alert billing staff
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Eligibility:
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Histologically confirmed adenocarcinoma of the colon. Stage II disease (T3-4, N0, M0) . At least 8 lymph nodes must have been evaluated . Distal extent of tumor must be => 12 cm from the anal verge by endoscopy or surgical examination. Has undergone surgical resection of the tumor between the past 28-60 days. No history of isolated, distant, or noncontiguous intra-abdominal metastases. Paraffin-embedded tumor specimen available. Prior/Concurrent Therapy:Biologic therapy: Not specified. Chemotherapy: Not specified. Endocrine therapy: Not specified. Radiotherapy: No prior radiotherapy for this cancer. Surgery: See Disease: haracteristics. More than 28 days since prior major surgery or open biopsy*. More than 7 days since prior core biopsy or other minor procedure except placement of a vascular access device*. [Note: *For patients with high-risk disease only]. Other: No prior systemic therapy for this cancer . No concurrent halogenated antiviral agents*.[Note: *For patients with high-risk disease only]
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Participating Sites:
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Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
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