Research and Clinical Trials

Title  
FOLFOX plus SIR-Spheres vs. FOLFOX Alone for Nonresected Liver Metastases
Brief Description  
This study is a randomized trial that will evaluate the addition of Selective Internal Radiation Therapy (SIRT) to the standard of care therapy for patients with liver metastases from primary colorectal cancer. The standard of care therapy for the purpose of this study is the FOLFOX 6m chemotherapy regimen.
Who may be Eligible  

  • Histologically confirmed adenocarcinoma of the colon or rectum, with or without primary tumor in stu
  • Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of trial entry.
  • Limited extra-hepatic metastases in the lung and/or abdominal lymph nodes are permitted. Metastases in the lung must not be more than five nodules in number with no nodule more than 1 cm in diameter. Involvement of abdominal lymph nodes are permitted provided they measure less than 2 cm in diameter.
  • Prior chemotherapy for metastatic colorectal cancer is not allowed. Patients may have received both adjuvant chemotherapy and/or radiotherapy following resection of the primary colorectal cancer, provided the last dose of chemotherapy and/or radiotherapy was administered at least 6 months prior to entry into this study.
  • WHO performance status 0 - 1
IRB Number  
03-11-13B
Principal Investigator  
Frenette, Gary

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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