Coordinating Center, NCCTG: N0147 CTSU: N0147 CALGB: N0147 ECOG: N0147 NCIC CTG: CRC.2 SWOG: N0147 North Central Cancer Treatment Group A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer Intergroup Study Chairs Steven R. Alberts, M.D. (Research Base)* Mayo Foundation 200 First Street, SW Rochester, MN 55905 Phone: (507) 284-1328 Fax: (507) 284-5280 E-mail:
[email protected] Statisticians Daniel J. Sargent, Ph.D. Mayo Foundation 200 First Street SW Rochester, MN 55905 E-mail:
[email protected] Michelle R. Mahoney, M.S. Fax: (507) 266-2477 Phone: (507) 284-8803 * Investigator having NCI responsibility for this protocol. DCTD Supplied Agent via Clinical Supplies Agreement (CSA): Cetuximab (NSC #714692) (Discontinued as of November 25, 2009) Commercial Supplied for patients pre-randomized following the implementation of Addendum 10: Oxaliplatin Document History (Effective Date) Document History (Effective Date) Activation February 10, 2004 NCCTG Addendum 7 January 4, 2008 NCCTG Update 1 February 10, 2004 NCCTG Addendum 8 May 12, 2008 NCCTG Addendum 1 March 29, 2004 NCCTG Addendum 9 August 18, 2008 NCCTG Addendum 2 September 1, 2004 NCCTG Update 3 August 18, 2008 NCCTG Addendum 3 June 1, 2005 NCCTG Addendum 10 May 8, 2009 NCCTG Addendum 4 June 1, 2005 NCCTG Addendum 11 December 18, 2009 NCCTG Addendum 5 August 1, 2005 NCCTG Addendum 12 September 22, 2010 NCCTG Addendum 6 August 15, 2007 NCCTG Addendum 13 June 1, 2011 NCCTG Update 2 August 15, 2007 NCI Version date: April 21, 2011 N0147 2 Addendum 13 Add As of November 25, 2009, all patient enrollments are complete.