Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma



Status:Completed
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/15/2016
Start Date:September 2009
End Date:December 2015

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

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.


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.
We found this trial at
1
site
St. Louis, Missouri 63108
?
mi
from
St. Louis, MO
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