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Research and Clinical Trials

Title  
CTSU E5202: Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
Brief Description  
This randomized Phase III trial is studying oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil or observation only in treating patients who have undergone surgery for stage II colon cancer. This project is being conducted at the following locations: Carolinas Medical Center/Blumenthal Cancer Center, Carolinas Hematology-Oncology Associates, and Mecklenburg Medical Group.
Who may be Eligible  

Patients, 18 years or older, may be eligible if they meet the following criteria:
  • Histologically confirmed adenocarcinoma of the colon
    • Stage II disease (T3-4, N0, M0)
  • Meets 1 of the following criteria:
    • High risk for microsatellite instability (MSI) and loss of heterozygosity (LOH) at chromosome 18q
      • Microsatellite stable (MSS) with 18q LOH
      • MSI-low grade (MSI-L) with 18q LOH
    • Low risk for MSI and 18q LOH
      • MSS with retention of 18q alleles
      • MSI-L with retention of 18q alleles
      • MSI-high grade (MSI-H) with retention of 18q alleles
      • MSI-H without retention of 18q alleles
      • MSI-H with 18q status uninformative
  • Distal extent of tumor must be = 12 cm from the anal verge by endoscopy or surgical examination
    • If tumor is located beyond sigmoid colon and centimeter distance is unavailable, include anatomic region of the colon (e.g., right colon, transverse colon, hepatic flexure, descending colon, or cecum)
  • Has undergone surgical resection of the tumor between the past 28-60 days
    • Must have had a complete resection (R0 resection)
  • No history of isolated, distant, or noncontiguous intra-abdominal metastases
  • Patients with synchronous tumors or appendiceal tumors are ineligible
  • Hereditary non-polyposis colorectal cancer allowed
  • Paraffin-embedded tumor specimen (one with normal mucosa and one from the resection tumor) available
Speciality/Disorder  
Gastrointestinal Cancer
IRB Number  
07-06-17B
Principal Investigator  
Limentani, Steven

For More Information, Contact  Delois  , DeShazo
Phone:  (704) 355-1342  Fax:  (704) 355-1353  
Email:  Delois.DeShazo @carolinashealthcare.org
Address:1100 South Tryon Street Suite 220 Charlotte, NC 28203
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