Clinical Research Directory

Inclusion Criteria: 1. Pathologically (histologically or cytologically) proven diagnosis of intrahepatic cholangiocarcinoma (IHC) without distant extrahepatic metastasis prior to study entry. Patients with an adenocarcinoma suggestive of a pancreaticobiliary primary with radiographic findings consistent with an intrahepatic cholangio-carcinoma are eligible. 2. Patient must have 1 lesion with a maximum AXIAL diameter of 12cm at the time of study entry. Up to 3 satellite lesions are permitted. Satellite lesions, are defined as lesions less than 2 cm that are within 1 cm of the periphery of the dominant lesion (gross tumor volume \[GTV\]) are permitted. The satellite lesions are NOT included in the AXIAL diameter measurement. Regional Lymph Node involvement within the porta hepatis (as medial as superior mesenteric vein \[SMV\] portal vein confluence) is permitted if nodes are deemed clinically positive (i.e. FDG \[Fluorine 18 fluorodeoxyglucose\] avid); 3. Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup: • Pre-study entry Scan (REQUIRED for All Patients to confirm no progression): computed tomography (CT) scan chest/abdomen/pelvis with multiphasic liver CT scan within 30 days prior to study entry. If CT contrast is contraindicated, CT chest without contrast and MRI of abdomen and pelvis is permitted; 4. Zubrod Performance Status 0-1 at the time of study entry; 5. Age ≥ 18; 6. Complete blood count (CBC) / differential obtained within 21 days prior to study entry, with adequate bone marrow function defined as follows: * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3; * Platelets ≥ 75,000 cells/mm3; * Total bilirubin \< 2.5 mg/dl; * Aspartate Aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (Serum glutamic pyruvic transaminase \[SGPT\]) \< 5.0 X institutional upper limit of normal; * Albumin ≥ 2.5mg/dl; * Creatinine within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m2 for subject with creatinine levels above institutional normal; * Hemoglobin(Hgb) ≥ 9.0 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable.) 7. Patient must provide study specific informed consent prior to study entry; 8. Negative Beta-Human Chorionic Gonadotropin (bHCG) prior to study entry if patient is pre or peri-menopausal. 9. Must have received 6 months of Gemcitabine/Cisplatin chemotherapy without progression. Disease response to chemotherapy is also permitted. If toxicity precludes 6 months of chemotherapy at least 4 months of Gemcitabine/Cisplatin must have been administered. Exclusion Criteria: 1. Multiple lesions that don't meet the criteria as satellite lesions as defined in protocol; 2. Extrahepatic metastases or malignant nodes beyond the periportal region. Celiac, pancreaticoduodenal and para-aortic nodes\> 2 cm are ineligible. Note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is \> 2.0 cm; 3. Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed at the time of study entry; 4. Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields; 5. Prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time; 6. Direct tumor extension into the stomach, duodenum, small bowel or large bowel; 7. Prior invasive malignancy, excluding the current diagnosis, (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. (Note: carcinoma in situ of the breast, oral cavity, or cervix is all permissible); 8. Prior systemic chemotherapy for the study cancer other than gemcitabine/cisplatin; note that prior chemotherapy for a different cancer is allowable; 9. Currently receiving other anti-cancer agents; 10. Participants who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin; 11. Prior surgery for the IHC. (Liver resection is not allowed); 12. Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months of study entry; * Transmural myocardial infarction within the last 6 months of study entry; * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry; * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to study entry; * HIV positive with CD4 (cluster of differentiation 4) count \< 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter at the time of study entry. Note also that HIV testing is not required for eligibility for this protocol; * End-stage renal disease (ie, on dialysis or dialysis has been recommended). 13. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic; 14. Grade 3 or higher peripheral neuropathy at the time of study entry.