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RAD 0901- Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma

19 Years
Not Enrolling
Hepatocellular Carcinoma, Liver Cancer

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Trial Information

RAD 0901- Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma

Inclusion Criteria:

- Child-Pugh class A or B7 cirrhosis.

- No prior radiation therapy to the upper right abdominal quadrant.

- Size of each tumor less than 6 cm.

- Three or less known lesions.

- More than 800 cc of uninvolved liver.

- Age > 19 years old

- ECOG Performance Status 0 or 1

- Adequate bone marrow, liver and renal function as assessed by the following:

- Hemoglobin > 8.5 g/dl

- Platelet count > 50,000/mm3

- Total bilirubin < 1.5 times ULN

- ALT and AST < 2.5 times the ULN ( < 5 x ULN for patients with liver involvement)

- Creatinine < 1.5 times ULN

- Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to the start of treatment

- Women of childbearing potential and men must agree to use adequate contraception
(barrier method of birth control) prior to study entry and for the duration of study
participation. Men should use adequate birth control for at least three months after
the last administration of sorafenib.

- Ability to understand and the willingness to sign a written informed consent. A
signed informed consent must be obtained prior to any study specific procedures.

- INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation
treatment with an agent such as warfarin or heparin may be allowed to participate.
For patients on warfarin, the INR should be measured prior to initiation of sorafenib
and monitored at least weekly, or as defined by the local standard of care, until INR
is stable.

Exclusion Criteria:

- Child-Pugh class B8 or C cirrhosis.

- ECOG greater than or equal to 2.

- Uncontrolled ascites despite medical management.

- Less than 800 cc of uninvolved liver.

- Prior radiotherapy to the upper abdominal quadrant.

- Prior antiangiogenic or tyrosine kinase inhibitor therapy Cardiac disease: Congestive
heart failure > class II NYHA. Patients must not have unstable angina(anginal
symptoms at rest) or new onset angina (began within the last 3 months) or myocardial
infarction within the past 6 months.

- Known brain metastasis. Patients with neurological symptoms must undergo a CT
scan/MRI of the brain to exclude brain metastasis.

- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.

- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic
pressure >90 mmHg, despite optimal medical management.

- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.

- Active clinically serious infection > CTCAE Grade 2.

- Thrombolic or embolic events such as a cerebrovascular accident including transient
ischemic attacks within the past 6 months.

- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of
study drug.

- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of
study drug.

- Serious non-healing wound, ulcer, or bone fracture.

- Evidence or history of bleeding diathesis or coagulopathy

- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
study drug.

- Use of St. John's Wort or rifampin (rifampicin).

- Known or suspected allergy to sorafenib or any agent given in the course of this

- Any condition that impairs patient's ability to swallow whole pills.

- Any malabsorption problem.

- Pregnant or lactating female.

Type of Study:


Study Design:

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

Outcome Measure:

Determine the safety and tolerability of sequential SBRT and sorafenib in patients with unresectable hepatocellular carcinoma

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Kimberly S Keene, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Institutional Review Board

Study ID:




Start Date:

November 2009

Completion Date:

June 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cancer
  • Hepatocellular carcinoma
  • HCC
  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



UABBirmingham, Alabama  35294