Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma

This study has been withdrawn prior to enrollment.
(Accrual below target levels)
Sponsor:
Collaborator:
Accuray Incorporated
Information provided by (Responsible Party):
Albert Koong, Stanford University
ClinicalTrials.gov Identifier:
NCT01327521
First received: March 30, 2011
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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.

Condition Intervention Phase
Carcinoma, Hepatocellular
Device: CyberKnife
Procedure: TACE
Drug: CT Contrast
Drug: doxorubicin
Drug: Epirubicin
Drug: 5-fluorouracil
Drug: Mitomycin C
Drug: Gemcitabine
Drug: Cisplatin
Device: SMANCS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: International Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Freedom from local progression at 6 months and 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: at 6, 12 and 18 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: at 6, 12, 18 months and up to 3 years ] [ Designated as safety issue: No ]
  • Serum AFP levels [ Time Frame: 1 month, 3 months, 6 months, 12 months and 18 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2011
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CyberKnife
    Standard of Care
    Other Name: CK
    Procedure: TACE
    Standard of Care
    Other Name: Transcatheter arterial chemoembolization
    Drug: CT Contrast
    Standard of Care
    Other Name: contrast dye
    Drug: doxorubicin
    Standard of Care
    Other Names:
    • Adriamycin
    • hydroxydaunorubicin
    Drug: Epirubicin
    Standard of Care
    Other Names:
    • Ellence
    • Pharmorubicin
    • Epirubicin Ebewe
    Drug: 5-fluorouracil
    Standard of Care
    Other Names:
    • 5-FU
    • f5U
    • Adrucil
    • Carac
    • Efudix
    • Efudex
    • Fluoroplex
    Drug: Mitomycin C
    Standard of Care
    Other Names:
    • Mutamycin
    • MTC
    Drug: Gemcitabine
    Standard of Care
    Other Name: Gemzar
    Drug: Cisplatin
    Standard of Care
    Other Names:
    • cisplatinum
    • cis-diamminedichloroplatinum(II)
    • CDDP
    • Platinol
    • Platinol-AQ
    Device: SMANCS
    Standard of Care
    Other Names:
    • styrene maleic acid neocarzinostatin
    • poppyseed oil
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327521

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Albert Koong
Accuray Incorporated
Investigators
Principal Investigator: Albert Koong Stanford University
  More Information

No publications provided

Responsible Party: Albert Koong, Associate Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT01327521     History of Changes
Other Study ID Numbers: HEP0030, ACCH001.0, SU-05052010-5862
Study First Received: March 30, 2011
Last Updated: June 7, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Fluorouracil
Epirubicin
Cisplatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014