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Phase II Study of Stereotactic Body Radiotherapy (SBRT) and Chemotherapy for Unresectable Cholangiocarcinoma Followed by Liver Transplantation

The purpose of this study is to determine progression-free survival at 12 months for stereotactic body radiotherapy (SBRT) and chemotherapy for unresectable hilar cholangiocarcinoma (CCA).

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Capecitabine
  • drug : Gemcitabine
  • drug : Cisplatin
  • drug : Carboplatin
  • drug : 5FU
  • procedure : Liver transplantation
  • procedure : Stereotactic Body Radiotherapy

Phase: Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Diagnosis of cholangiocarcinoma by any of the below: - Positive transcatheter biopsy or brush cytology - CA 19-9 &#8805; 100mg/mL with a malignant-appearing stricture on cholangiography - Biliary ploidy by fluorescent in situ hybridization with a malignant stricture on cholangiography - Liver tumors not to exceed 8 cm in greatest axial dimension (800 cc of uninvolved liver) - Unresectable tumor above cystic duct - Hepatic lesion in patients for whom surgical resection is not possible or would not result in an opportunity for cure by any of the below: - Bilateral segmental ductal extension - Encasement of the main portal vein - Unilateral segmental ductal extension with contralateral vascular encasement - Unilateral atrophy with either contralateral segmental ductal or vascular (hepatic artery, portal vein) involvement - Ascites is allowed if the Model for End-Stage Liver Disease (MELD) score is <15[1] - Age > 18 years old - Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix 1) - Lab values within 2 wks prior to randomization: - See STUDY SCHEMA for specific blood count inclusion criteria: ANC &#8805; 500 x 109/L (&#8805; 1500/mm3), Platelets &#8805; 5 x 109/L (&#8805; 50,000/mm3), Hgb &#8805; 9g/dL - Adequate liver function: Total bilirubin &#8804;1.5 x upper limit of normal (ULN); ALT and/or AST & alkaline phosphatase &#8804; 5 x ULN. - Adequate biliary drainage, with no evidence of active uncontrolled infection (patients on antibiotics are eligible). - See STUDY SCHEMA for specific renal function inclusion criteria: Adequate renal function with a calculated GFR &#8805; 40 ml/min. If the calculated GFR is below 40 ml/min a 24 hour urine creatinine clearance can be used. - Albumin > 2.5 mg/dL - INR &#8804; 1.5 - Life expectancy > 6 months - Capable of giving written informed consent

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
ccto-office@stanford.edu
650-498-7061

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