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E5202 -- Oxaliplatin/5-FU/Leucovorin (FOLFOX) vs FOLFOX + Bevacizumab for Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers

The purpose of this study is to demonstrate an improvement in 3-year disease-free survival for high risk stage II colon cancer patients randomly assigned to 5-FU, leucovorin, and oxaliplatin (FOLFOX) versus FOLFOX plus bevacizumab.


Eligibility

You may be eligible for this trial if:

  • You have histologically confirmed Stage II adenocarcinoma of the colon (T3,4 N0 M0)
  • The distal extent of your tumor is > 12 cm from the anal verge as determined via endoscopy or surgery.
  • You must have ≥ 8 lymph nodes evaluated and reported.
  • You must not have isolated, distant, or non-contiguous intra-abdominal metastases, even if restricted.
  • You must not have presented with complete obstruction or perforation of the bowel.
  • You must not have had any systemic or radiation therapy for this malignancy.
  • You are at least 18 years old
  • You must begin adjuvant treatment between 28-60 days post-surgery.

Trial Sponsor

  • Eastern Cooperative Oncology Group (ECOG)

Project Begin Date

  • Aug 2007

Tentative Project End Date

  • Aug 2012

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .