Trial Search Results

Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma

Primary Objective:

To compare the efficacy of TACE vs. CyberKnife SBRT in the treatment of locally recurrent HCC after initial TACE.

Secondary Objectives:

1. To determine the progression-free survival of TACE vs. CyberKnife SBRT

2. To determine the overall survival of TACE vs. CyberKnife SBRT for locally recurrent HCC

3. To determine the toxicities associated with TACE or CyberKnife SBRT for the treatment of recurrent HCC.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Albert Koong

Collaborator: Accuray Incorporated

Intervention(s):

  • Device: CyberKnife
  • Procedure: TACE
  • Drug: CT Contrast
  • Drug: doxorubicin
  • Drug: Epirubicin
  • Drug: 5-fluorouracil
  • Drug: Mitomycin C
  • Drug: Gemcitabine
  • Drug: Cisplatin
  • Device: SMANCS

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Confirmed hepatocellular carcinoma by one of the following:

      - Histopathology

      - One radiographic technique that confirms a lesion >=2 cm with arterial
      enhancement with washout on delayed phase

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

   - Radiographic evidence of persistent, progressive or recurrent disease in an area
   previously treated with TACE. This evaluation should be determined after 6 weeks of
   initial TACE

   - Multi-specialty evaluation whereby the recurrent liver lesion was deemed by both the
   attending radiation oncologist and interventional radiologist amenable to treatment by
   the respective modality

      - Eligible patients must undergo an IV contrast CT scan of the liver within 6 weeks
      of enrollment onto the study; a contrast enhanced liver MRI may be substituted
      for the IV contrast CT of the liver.

      - A recent serum AFP must also be obtained within 4 weeks of enrollment.

   - Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension. Multifocal
   lesions will be restricted to lesions that can be treated within a single target
   volume within the same liver segment and to an aggregate of 7.5cm as long as the dose
   constraints to normal tissue can be met

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

   - Patients with liver disease classified as Child Pugh class A/B; if Child's class B,
   score must be 8 or less

   - Albumin >= 2.5 g/dL

   - Total bilirubin <= 3 mg/dL

   - INR <= 1.5

   - Creatinine <= 2.0 mg/dL

   - Age >= 18 years old

   - Life expectancy>= 6 months

   - Ability of the research subject or authorized legal representative to understand and
   the willingness to sign a written informed consent document.

Exclusion Criteria:

   - Prior radiation for the recurrent liver tumors

   - Prior radiotherapy to the upper abdomen

   - Prior RFA to index lesion

   - Liver transplant

   - Tumors >= 7.5 cm in greatest axial dimension

   - Portal vein thrombus

   - Large varices within 2 cm of index lesion (seen on cross section imaging)

   - Contraindication to receiving radiotherapy

   - Active gastrointestinal bleed within 2 weeks of study enrollment

   - Ascites refractory to medical therapy

   - Women who are pregnant

   - Administration of any systemic chemotherapy within the last 1 month

   - Presence of multifocal lesions located in different lobes of the liver or extrahepatic
   metastases

   - Participation in another concurrent SYSTEMIC treatment protocol

   - Prior history of malignancy other than HCC

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
Laurie Ann Columbo
6507360792
Not Recruiting