Research and Clinical Trials

Brief Description  
The purpose of this study is to find out what effects (good and bad), Capecitabine, Gemcitabine, and radiation have on Extra Hepatic Cholangiocarcinoma (EHCC). The goals of this study are to determine the survival and local-regional control rates associated with a common adjuvant regimen. The results would serve as a baseline for testing future regimens.
Who may be Eligible  

Patient must have a histopathological diagnosis of extrahepatic cholangiocarcinoma (gallbladder or bile duct). Patient must not have ampullary cancer. Patient must have at least one of the following:
  • pathological T2-4 disease (see Section 4.0)
  • pathological N1 disease (see Section 4.0)
  • positive margins (any T or N stage)
Patient must not have distant metastatic disease as indicated by a CT or MRI of the chest, abdomen, and pelvis within 42 days prior to registration. Positive resected regional lymph nodes are allowed. Patient must have received a potentially curative radical resection with negative (R0) or microscopically positive (R1) margins. Resection must have been performed within 56 days prior to registration and patient must have recovered from any complications. Patient must not have received any prior chemotherapy or radiotherapy for this disease. Patient must have had no previous upper abdominal radiation therapy for any reason at any time.
Speciality/Disorder  
Gastrointestinal Cancer
IRB Number  
04-09-03A
Principal Investigator  
Salmon, Stuart

For More Information, Contact  Tesa  M, Adams
Phone:  (704) 355-5145  Fax:  (704) 355-1352  
Email:  tesa.adams@carolinashealthcare.org
Address:1100 South Tryon Street Suite 220 Charlotte, NC 28203
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