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Feasibility of Hypofractionated Stereotactic Radiotherapy in Patients With Hepatocellular Carcinoma

Phase 1
19 Years
Open (Enrolling)
Liver Cancer

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Trial Information

Feasibility of Hypofractionated Stereotactic Radiotherapy in Patients With Hepatocellular Carcinoma



- To determine the safety of hypofractionated stereotactic radiotherapy (SRT) in patients
with advanced hepatocellular carcinoma.


- To determine the maximum tolerated dose of SRT in these patients.

- To determine the objective tumor response rate in terms of the percentage of tumor size
change on CT, percentage of intensity change on MRI, and the percentage of change in
alfa fetoprotein in patients treated with this therapy.

- To determine the value of 4-dimensional CT in liver cancer planning in terms of the
extent of liver motion (three dimensionally) and the percentage of patients requiring
breath gating due to the amplitude of organ motion exceeding 1 cm in any dimension.

- To determine the value of breath gating in liver cancer SRT in terms of the success
rate of breath gating and the percentage of treatment time prolongation secondary to
the gating.

OUTLINE: Patients undergo hypofractionated stereotactic radiotherapy once daily on days 1-5.

After completion of study therapy, patients are followed at 1 and 3 months.

Inclusion Criteria


- Histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC)

- Measurable disease, defined as ≥ 1 unidimensionally target lesion that can be
accurately measured by CT scan or MRI according to RECIST and must have a maximum
diameter ≤ 8 cm

- No known CNS tumors, including metastatic brain disease

- Child-Pugh class A-B cirrhotic status


- Karnofsky performance status 60-100%

- Life expectancy ≥ 12 weeks

- WBC ≥ 2,000/μL

- Platelet count ≥ 60,000/mm³

- Hemoglobin ≥ 8.5 g/dL

- INR ≤ 2.3

- No malignancy within the past 3 years that is distinct in its primary site or
histology from HCC, except for carcinoma in situ of the cervix, treated basal cell
carcinoma, or superficial bladder tumors (i.e., Ta, Tis, and T1), or any other cancer
that has been curatively treated > 3 years prior to study entry

- No renal failure requiring hemodialysis or peritoneal dialysis

- No uncontrolled intercurrent illness including, but not limited to, any of the

- Ongoing or active infection > grade 2

- NYHA class II-IV congestive heart failure

- Active coronary artery disease

- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers
or digoxin

- Uncontrolled hypertension

- Condition that could jeopardize the safety of the patient or study compliance

- More than 6 months since prior myocardial infarction

- No history of variceal bleeding where the varices have not been eradicated or
decompressed by shunt placement

- No condition that would prevent the patient from undergoing marker implantation

- Not pregnant or nursing

- Negative pregnancy test

- No substance abuse, medical, psychological, or social condition that may interfere
with the patient's participation in the study or evaluation of the study results


- Prior systemic chemotherapy allowed

- At least 6 weeks since prior non-radiation local therapy (e.g., surgery, hepatic
arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol
injection, or cryoablation)

- No prior radiotherapy to the liver

- Concurrent therapeutic anticoagulation (e.g., warfarin or heparin) allowed provided
that no prior evidence of underlying abnormality in PT, PTT, INR exists

Type of Study:


Study Design:

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

Outcome Measure:

Toxicity as assessed by NCI CTCAE v3.0

Outcome Time Frame:

Up to 1 month after SRT

Safety Issue:


Principal Investigator

Chi Lin, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska


United States: Institutional Review Board

Study ID:




Start Date:

November 2007

Completion Date:

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680