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Multi-institution Phase I/II Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Carcinoma, Hepatocellular

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Trial Information

Multi-institution Phase I/II Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma

Despite recent advances in early detection and diagnosis, only 30-40% of patients with
hepatocellular carcinoma may benefit from radical therapies. Liver transplantation offers
the best chance for cure. Surgical resection has been the only other potentially curative
option, but the majority of patients are not candidates for resection. This reflects the
usual comorbidity of severe underlying liver disease that either precludes surgery or makes
the surgical approach extremely dangerous.

Inclusion Criteria:

Evaluation by the Surgery and/or Liver Transplant Team has been performed and the patient
is not considered a candidate for either "standard" therapy to target area (upper abdomen)

- Adequate liver function defined as:

- total bilirubin < 3mg/dl, albumin > 2.5 g/dl

- normal PT/PTT unless on anticoagulants

- mild elevation of liver enzymes acceptable (must be less than three times upper
limit of normal)

- Adequate renal function (creatinine < 1.8 mg/dl or creatinine clearance ≥ 50 ml/min)

- Adequate bone marrow reserve:

- ANC count ≥ 1500 mm3

- Platelets ≥ 50,000/mm3

- Hemoglobin > 9 g/dL

NOTE: Lab values must be obtained within 2 weeks prior to being registered for protocol

Exclusion Criteria:

- No history of systemic lupus erythematous, rheumatoid arthritis, systemic sclerosis
or scleroderma

- No chemotherapy within 14 days before radiotherapy (chemotherapy may cause transient
hepatitis with hepatomegaly)

- No subsequent chemotherapy planned within 2 weeks of radiotherapy

- No active liver infection

- No acute Hepatitis. Definition of active disease:

- Hepatitis A: Acute hepatitis determined by presence of Anti-HAV-

- Hepatitis B:

1. HBsAg (HB surface Antigen): present in patients with acute and chronic

2. HBV DNA present in patients with active viral replication in amounts
greater than 100,000 copies

3. HBeAg is present in wild type HBV infection and suggests active replication

4. Anti-HBs: Antibody against HBsAg appears after HBV infections and confers

5. Anti-HBc-IgM: Antibody against HBcAg, fraction IgM, present in acute
infection and often could be detected during periods of high viral
replication in chronic disease

6. Anti-HBc-IgG: is present in chronic disease

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine 6 month local in-field control of this patient population

Outcome Time Frame:

2 years from enrollment completion

Safety Issue:


Principal Investigator

Higinia Cardenes

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

May 2004

Completion Date:

December 2015

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular



Indiana University Department of Radiation Oncology Indianapolis, Indiana  46202