Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma

Not Recruiting

Trial ID: NCT01020812


To determine the efficacy and toxicity of TACE combined with SBRT

Official Title

Phase II Study of Combination Stereotactic Body Radiotherapy (SBRT) With Transarterial Chemo-Embolization (TACE) for Unresectable Hepatocellular Carcinoma

Stanford Investigator(s)

Aya Kamaya, MD
Aya Kamaya, MD

Professor of Radiology (Body Imaging)

Brendan C. Visser, MD
Brendan C. Visser, MD

Professor of Surgery (General Surgery)

Samuel So, MD
Samuel So, MD

Lui Hac Minh Professor in the School of Medicine

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine

Daniel Sze, MD, PhD
Daniel Sze, MD, PhD

Professor of Radiology (Interventional Radiology)

Nishita Kothary, MD
Nishita Kothary, MD

Professor of Radiology (Interventional Radiology)

Lawrence "Rusty" Hofmann, MD
Lawrence "Rusty" Hofmann, MD

Professor of Radiology (Interventional Radiology)


Inclusion -

   - Liver tumors treatable by SBRT not to exceed 10cm in greatest axial dimension.

      - 800 cc of uninvolved liver

      - Patients may have additional hepatic lesions if they are <3cm and can be treated
      with TACE or RFA.

   - Age > 18 years old

   - Albumin > 2.4 g/dL.

   - Total bilirubin < 3 mg/dL.

   - INR ≤ 1.5.

   - Creatinine < 2.0 mg/dL.

   - Confirmed hepatocellular carcinoma by one of the following:

      - Histopathology

      - Two radiographic techniques (out of US, MRI, CT, Angiography) that confirm a
      lesion >2 cm with arterial hypervascularization

      - One radiographic technique that confirms a lesion >2 cm with arterial
      hypervascularization and an elevated AFP

   - Hepatic lesion in patients for whom surgical resection is not possible or would not
   result in an opportunity for cure

   - Tumor(s) <10cm

   - Eastern Clinical Oncology Group performance status 0, 1 or 2

   - No prior surgery, chemotherapy, or radiation for the current tumor

   - Patients placed on the liver transplant registry are eligible for this trial, but will
   be withdrawn from the protocol if they receive liver transplantation.

   - TACE done prior to study enrollment is allowed if there were no more than 3 procedures
   within an 18 week period and SBRT can begin within 12 weeks of the last TACE

Exclusion -

   - Prior radiotherapy to the upper abdomen

   - Prior TACE, RFA, or liver transplant

   - Tumor(s) ≥ 10cm

   - Large esophageal varices without band ligation

   - Active GI bleed or within 2 weeks of study enrollment

   - Ascites refractory to medical therapy

   - Contraindication to receiving radiotherapy

   - Women who are pregnant

   - Administration of any systemic cytotoxic agents within the last 12 months

   - Presence of extrahepatic metastases

   - Participation in another concurrent treatment protocol


procedure: TACE

procedure: SBRT

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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