Combination SBRT (Stereotactic Body Radiotherapy) With TACE (Transarterial Chemoembolization) for Unresectable Hepatocellular Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01020812
First received: November 24, 2009
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

To establish the efficacy and toxicity of TACE combined with SBRT


Condition Intervention Phase
Carcinoma, Hepatocellular
Hepatobiliary Neoplasm
Liver Carcinoma
Procedure: TACE
Procedure: SBRT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Combination Stereotactic Body Radiotherapy (SBRT) With Transarterial Chemo-Embolization (TACE) for Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To establish the efficacy and toxicity of TACE combined with SBRT. [ Time Frame: Every year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the progression-free survival of TACE and SBRT [ Time Frame: every year ] [ Designated as safety issue: No ]
  • To determine the overall survival of TACE and SBRT [ Time Frame: every year ] [ Designated as safety issue: No ]
  • To correlate the tumor marker alpha-fetoprotein (AFP) with tumor response and survival. [ Time Frame: every year ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic body radiotherapy (SBRT)

SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.

Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction

Procedure: TACE
Standard of Care
Other Names:
  • Transcatheter arterial chemoembolization
  • Transarterial Chemoembolization
Procedure: SBRT
Standard of Care
Other Name: stereotactic body radiotherapy

Detailed Description:

Hepatocellular carcinoma (HCC) is the third most deadly cancer in the world. It is primarily seen in areas where hepatitis is endemic, such as Asia, but other risk factors include alcoholic cirrhosis.

Outcome of this disease is poor, mostly due to the fact that >80% of patients present with unresectable disease. Surgery or transplantation remain the only curative options. For the vast majority of patients who are unresectable, a variety of treatment options are available, including transarterial chemo-embolization (TACE), radiofrequency ablation, radioactive microspheres, microwave coagulation, laser-induced thermotherapy, and percutaneous alcohol injection, all of which have similar survival rates. Stereotactic body radiotherapy (SBRT) for unresectable HCC is a relatively new treatment option made available because of great improvements in diagnostic imaging and radiation delivery techniques. Although follow-up is limited, results show encouraging local control rates. Some investigators have combined TACE with fractionated radiotherapy as a means of intensifying local therapy, with some evidence of benefit.

TACE remains the dominant mode of local therapy for unresectable HCC. However, recurrence rates are high. The recent randomized trial suggests that a combination of local therapy (TACE and radiofrequency ablation [RFA]) is superior to either therapy alone, providing proof of principle that combined local treatment is most likely more effective for HCC. Because SBRT is rapidly becoming an accepted local therapy for hepatic lesions, its role in treating HCC needs to be further defined. Studies combining TACE and external beam radiotherapy have shown encouraging results, so the logical next step is to combine TACE with SBRT, which delivers a radiobiologically more intensive dose of radiation. However, toxicity data are lacking, since this combination has not been previously reported.

We propose to conduct a trial of trans-arterial chemo-embolization (TACE) and SBRT for unresectable HCC.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01020812

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Daniel T Chang Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01020812     History of Changes
Other Study ID Numbers: HEP0024, SU-09112009-3882
Study First Received: November 24, 2009
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on August 21, 2014