Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
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. [ Time Frame: Up to 90 days after end of radiation therapy ]
Secondary Outcome Measures :
Measure the late toxicity associated with using stereotactic radiation therapy in patients with unresectable HCC and IHC. [ Time Frame: 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 Frame: 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. [ Time Frame: Baseline to time of death ]
Measure the response rates associated with using SBRT in patients with resectable HCC and IHC [ Time Frame: Baseline to the first date of recurrance or progressive disease ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.