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Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma, Hepatic Metastasis

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Trial Information

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.

Inclusion Criteria:

- Patients with hepatocellular carcinoma or hepatic metastases from a solid malignancy,
unsuitable for radical therapy (including resection, transplant, conformal high dose
radiotherapy), confirmed by biopsy or imaging

- Symptoms of hepatic pain, discomfort, nausea, or fatigue requiring palliation

- KPS>60

- Expected survival of greater than 3 months

- Platelet count > 25 bil/L, Hemoglobin > 70 g/L, INR<3, Bilirubin<100 umol/L, AST <
350 U/L or ALT< 400 U/L

- Have signed an informed consent form approved by the Research Ethics Board (REB) at
Princess Margaret Hospital

Exclusion Criteria:

- Chemotherapy or novel drug within the past 2 weeks

- TACE(transarterial chemoembolization)within the past 1 month

- Plan for active treatment of the hepatocellular carcinoma or hepatic metastases,
including TACE or RFA or ETOH injection

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Laura Dawson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital


Canada: Ethics Review Committee

Study ID:

UHN REB 07-0020-CE



Start Date:

February 2007

Completion Date:

November 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatic Metastasis
  • Hepatocellular Carcinoma
  • Hepatic Metastasis
  • Palliative Radiation Therapy
  • Locally advanced HCC and Hepatic Metastasis
  • Carcinoma
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms
  • Carcinoma, Hepatocellular