Trial Search Results

Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma

To determine the efficacy and toxicity of TACE combined with SBRT

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Procedure: TACE
  • Procedure: SBRT

Phase:

Phase 1/Phase 2

Eligibility


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   be withdrawn from the protocol if they receive liver transplantation.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
   procedure.

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
ccto-office@stanford.edu
650-498-7061