Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases
The liver is one of the most common sites with tumour involvement, including both primary
and metastatic disease. Gastrointestinal tumours, breast, lung and melanoma are the most
common primary sites for hepatic metastases. Hepatocellular carcinoma(HCC) is the sixth most
common cancer worldwide, with over 600,000 new cases diagnosed per year. It is the third
most common cause of cancer related death.Although, predominately a disease in Asia and
sub-Saharan Africa, the incidence of HCC is increasing in North America. The use of
radiation in unresectable hepatocellular carcinomas, as well as hepatic metastases, for
palliation is uncommon in clinical practice.
This may be because there is a prevailing perception that radiation to the liver will
inevitably lead to radiation induced liver disease (RILD). However, several single
institution, predominantly retrospective studies, have demonstrated effective palliation for
locally advanced HCC as well as hepatic metastases with minimal toxicity.In this study,
palliative radiotherapy (RT), delivered in one fraction of 8Gy, will be given to symptomatic
patients who are not candidates for radical treatment. We hypothesize that palliative RT
will provide symptomatic relief to a large fraction of the patients, with both primary and
metastatic disease. We also expect minimal toxicities at this treatment dose.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
To determine the change in index symptom(s) using an 11 point numerical rating scale for patients with locally advanced hepatocellular cancer or hepatic metastases treated with 8Gy
5 years
No
Laura Dawson, MD
Principal Investigator
University Health Network, Princess Margaret Hospital
Canada: Ethics Review Committee
UHN REB 07-0020-CE
NCT00923897
February 2007
November 2013
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