Current Research: Medical Oncology

E5204 -- Postoperative Oxaliplatin/5-FU/Leucovorin (FOLFOX) vs FOLFOX + Bevacizumab for Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation

The primary objective of this study is to compare the overall survival of patients with clinical Stage II and III rectal cancer who received pre-operative chemoradiation and were treated with oxaliplatin, leucovorin, and 5-fluorouracil with or without bevacizumab postoperatively.

Eligibility

You may be eligible for this trial if:

• You have histologically-proven adenocarcinoma of the rectum with no distant metastases; Clinical stage T3N0M0, T4 N0M0, or TanyN1-2M0.
• You have no evidence of tumor outside the pelvis including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy.
• You have prior minimum radiation dose of 40-55.8 Gy. Prior IMRT is allowed.
• You have a completely resected tumor and are able to start treatment between 28-56 days from the date of surgery.
• The rectal location of the tumor must be confirmed either prior to neoadjuvent therapy or at the time of surgery.
• Your tumor may be clinically fixed or initially not completely resectable.
• You cannot have had prior chemotherapy or pelvic radiation except as neoadjuvent treatment for current diagnosis as stated above.

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 .