Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

Completed · Phase 1

Conditions studied: Carcinoma, Hepatocellular, Intrahepatic Cholangiocarcinoma

In brief

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.

Key facts

Study ID

NCT01668134

Run by

Washington University School of Medicine

People needed

28

Starts

2009-12-16

Expected to finish

2015-12-22

Last updated by the study team

2017-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.