Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

Study Overview
=================
Brief Summary
-----------------
This study is being done to determine if targeted radiation therapy (stereotactic) can be given to treat liver cancer, for patient who are unable to undergo surgery, over a short period of time with a small amount of side effects.

Official Title
-----------------
Feasibility Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

Conditions
-----------------
Carcinoma, Hepatocellular, Intrahepatic Cholangiocarcinoma

Intervention / Treatment
-----------------
* Radiation: Stereotactic radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Karnofsky Performance Status of ≥ 60 Pathologically confirmed IHC or HCC. (Pathology not required for HCC if the lesion enhances typically on MRI and the patient is evaluated by liver transplant surgery team and thought to have HCC.) 4 or less separate intrahepatic lesions, with at least one lesion that is able to be followed by EASL Criteria. Local surgical resection is not possible due to tumor or patient factors Limited metastatic disease is allowed if the volume of metastatic disease does not exceed the volume of primary disease. Prior TACE allowed if stopped/completed at least 2 weeks prior to enrollment Prior chemotherapy except Sorafenib allowed if stopped/completed at least 2 weeks prior to enrollment Prior Sorafenib allowed if stopped/completed at least seven days prior to enrollment. Able to provide signed informed consent Exclusion Criteria: Childs-Pugh score 9 or more ALT or AST ≥ 6 x upper limit of normal Prior history of abdominal irradiation Women who are pregnant or nursing Scheduled to undergo chemotherapy except Sorafenib at the time when radiation therapy will be given, or for up to 4 weeks after completion of radiation therapy. Scheduled to undergo Sorafenib within seven days of when radiation therapy will be delivered, or for up to 2 weeks after completion of radiation therapy. Undergone prior radiation therapy to the abdomen.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic radiation<br> | Radiation: Stereotactic radiation<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stereotactic radiation therapy (either photon or proton) can be delivered to the liver with a less than 10% 3-month incidence of Grade 4 study related toxicity. |  | Up to 90 days after end of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the late toxicity associated with using stereotactic radiation therapy in patients with unresectable HCC and IHC. |  | Up to 60 days after end of radiation therapy | 
| Measure the local recurrence rates associated with using SBRT in patients with unresectable HCC and IHC. |  | Time of treatment until recurrance or progressive disease as measured by CT/MR from baseline to recurrance or progressive disease | 
| Measure the overall survival rates associated with using SBRT in patients with unresectable HCC and IHC. |  | Baseline to time of death | 
| Measure the response rates associated with using SBRT in patients with resectable HCC and IHC |  | Baseline to the first date of recurrance or progressive disease |