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Downstaging of Hepatocellular Carcinoma by Stereotactic Body Radiotherapy for Non-Resectable and Non-Transplantable Tumors: Phase 2 Study


Phase 2
18 Years
70 Years
Not Enrolling
Both
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer

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Trial Information

Downstaging of Hepatocellular Carcinoma by Stereotactic Body Radiotherapy for Non-Resectable and Non-Transplantable Tumors: Phase 2 Study


PRIMARY OBJECTIVES:I. To determine in patients with stage B and C Hepatocellular Carcinoma,
if Stereotactic Body Radiotherapy can achieve a downstaging rate of >= 30% at 3
months.SECONDARY OBJECTIVES:I. To determine in patients with stage B and C Hepatocellular
Carcinoma, if Stereotactic Body Radiotherapy can achieve a downstaging rate of >= 30% at 3
and 6 months.II. To determine the rate of Grade 3 or 4 adverse events associated with SBRT
for liver tumors. III. To determine the rate of local progression after SBRT. (Based
onRECIST criteria)IV. To determine the number of patients who achieve liver
transplantation.OUTLINE:Patients undergo 3 fractions of stereotactic body radiation therapy
delivered within 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 2 years.


Inclusion Criteria:



- HCC is staged as Barcelona B or C (non-resectable and non-transplantable)

- Treatment with SBRT can occur within 6 weeks of staging laparoscopy

- Patient has a) Radiographic enhancing liver lesions on triple phase CT or MRI and b)
Histological confirmation of HCC

- Patients with clinical/imaging features of HCC but without biopsy confirmation can be
initially enrolled on the protocol and undergo staging laparoscopy for biopsy
confirmation with the option of having the fiducials placed in the same procedure;
but if the histology is not confirmed and/or other exclusion criteria is met patient
will be taken off protocol

- Total aggregate of maximal dimension of liver tumors =< 8 cm

- Cirrhotic patients Child Pugh Class A or B

- Patient should be medically eligible for liver transplantation

- Absolute neutrophil count > 1,500/ul

- Platelets > 50,000 ul (after transfusion if required)

- Hemoglobin greater than 10.0 g/dL

- Total bilirubin < 2.0 mg/dL

- AST(SGOT)/ALT(SGPT) < 2 X institutional upper limit of normal

- Life expectancy > 12 weeks

- ECOG performance status < 2 or Karnofsky >= 70%

- Women of child-bearing potential must have a negative pregnancy test within 4 weeks
to the start of the SBRT treatment

- Women must not be pregnant or nursing

- Sexually active men and women must agree to use accepted forms of birth control

- Provision of informed consent: Patient must be able to provide verbal and written
informed consent

Exclusion Criteria:

- Patient with previous history of abdominal radiation

- Prior invasive malignancy other than primary liver malignancy (except
non-melanomatous skin cancer) unless disease free for a minimum of 3 years

- Evidence of metastatic disease prior to staging laparoscopy

- Evidence of main Portal Vein thrombosis

- History of cardiac ischemia or stroke within last 6 months

- Any concurrent medical or psychosocial condition that prohibits a major surgical
procedure or immunosuppression that would constitute a contraindication to liver
transplantation

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of downstaging of stage B and C Hepatocellular Carcinoma using Stereotactic Body Radiotherapy

Outcome Time Frame:

At 3 months

Safety Issue:

No

Principal Investigator

Juan Sanabria

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CASE3209

NCT ID:

NCT01194206

Start Date:

August 2010

Completion Date:

March 2012

Related Keywords:

  • Adult Primary Hepatocellular Carcinoma
  • Advanced Adult Primary Liver Cancer
  • Localized Unresectable Adult Primary Liver Cancer
  • Recurrent Adult Primary Liver Cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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