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Phase II Trial of Stereotactic Body Radiation Therapy for Unresectable Hepatocellular Carcinoma

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Phase II Trial of Stereotactic Body Radiation Therapy for Unresectable Hepatocellular Carcinoma

From July 2003 to May 2007, over 40 patients with hepatocellular carcinoma participated in
two studies at Princess Margaret Hospital (PMH) designed to determine the safety of treating
hepatocellular carcinoma with SBRT. These studies have shown that SBRT can be delivered
safely to the majority of patients with hepatocellular carcinoma. The treated tumour was
controlled (shrank or remained the same size) in 78% of patients at one year following
treatment.The median survival of patients was 11 months (i.e. half of patients survived
longer and half shorter than 11 months). This survival rate is better than that expected in
patients treated with supportive care only (no treatment other than care to make you feel
better). Supportive care patients have a median survival rate of 3-9 months. We expect that
the benefits of SBRT in this study will be similar to those observed in our initial studies.

Inclusion Criteria:

- Confirmed pathologically, 2)diagnosed by showing vascular enhancement of the lesion
on at least two imaging techniques, or 3) diagnosed by showing vascular enhancement
on a single technique if the AFP is greater than 200, in the setting of cirrhosis or
chronic hepatitis B without cirrhosis (EASL consensus conference guidelines).

- Either 1) the tumour must be unresectable, based on the opinion of an experienced
surgeon specializing in hepatic resection, or 2) the patient Phase II SBRT HCC 13
must be medically inoperable, or 3) extra-hepatic metastases must be present (making
hepatic surgery an inappropriate treatment option).

- Karnofsky performance status (KPS) > 60 (Appendix II)

- Age: 18 years or older. Both male & female patients of all races can be included in
this study. Female patients within reproductive years may not be, nor become,
pregnant during participation in this study

- Patients must have recovered from the effects of previous therapy.

- Maximal tumor size of 15 cm.

- Adequate organ function as assessed as follows:

- Hemoglobin > 90 g/L

- Absolute neutrophil count > 1.0 bil/L

- Platelets > 50 bil/L

- Bilirubin < 4.0 times upper range of normal

- INR < 1.5 or correctable with vitamin K (unless patient is on coumadin in which
case higher levels are acceptable)

- AST or ALT < 6.0 times upper range of normal

- Child's A 5-6 liver score or Child B 7-8 liver score, which is only permitted if the
maximal tumor size is 10 cm

- Previous liver resection or ablative therapy is permitted.

- Life expectancy > 3 months

- The volume of uninvolved must be at least 700 cc

- Up to five discrete liver tumors

- Patients must have signed a study-specific informed consent form. If the patient's
mental status precludes this, written informed consent may be given by the patient's
legal representative.

Exclusion Criteria:

- Patients with active hepatitis or encephalopathy related to liver failure

- Prior radiation therapy to the right upper abdomen, precluding reirradiation of the
liver. That is, any previous radiation therapy in which a mean dose to the liver of
15 Gy in conventional fractionation was delivered, or previous doses to critical
normal structures that would make re-irradiation unsafe. The PI should be called if
there is any question of safety of re-irradiation.

- Eligible for RFA or alcohol ablation

- Eligible for TACE

- Prior uncontrolled, life threatening malignancy within the six months.

- Pregnancy is not permitted, and in women of child bearing age, a pregnancy test and
acceptable methods of contraception are warranted.

- Previous gastric, duodenal or variceal bleed within the past 2 months.

- Commencement of coumadin use within the past 3 months.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine one year local progression free rate, defined as lack of progression within the irradiated volume, using RECIST criteria

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 07-0346-C



Start Date:

August 2007

Completion Date:

August 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • Stereotactic Body Radiation
  • Unresectable liver cancer
  • Patients with Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular