Clinical Trial: Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Feasibility Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma
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.
Detailed Summary:
Sponsor: Washington University School of Medicine
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Washington University School of Medicine
Dates:
Date Received: August 8, 2012
Date Started: December 16, 2009
Date Completion:
Last Updated: February 16, 2017
Last Verified: February 2017
