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Transarterial Chemoembolization (TACE) vs. CyberKnife for Recurrent Hepatocellular Carcinoma (HCC)

Primary Purpose

Recurrent Hepatocellular Carcinoma

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Transarterial Chemoembolization
CyberKnife SBRT
Sponsored by
Accuray Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Hepatocellular Carcinoma focused on measuring Primary liver cancer, Hepatocellular carcinoma, CyberKnife, Accuray, TACE, Transarterial chemoembolization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed hepatocellular carcinoma by one of the following:

    1. Histopathology
    2. 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

    1. 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 contrast liver CT
    2. A recent serum AFP must 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 7.5 cm as long as the dose constraints to normal tissue can be met.
  • Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix I).
  • Patients with liver disease classified as Child Pugh class A/B, if Child's class B, score must be 8 or less.
  • Life expectancy >= 6 months
  • Age >= 18 years old
  • Albumin >= 2.5 g/dL
  • Total Bilirubin <= 3 mg/dL
  • INR <= 1.5
  • Creatinine <= 2.0 mg/dL
  • Both men and women and members of all races and ethnic groups are eligible for this study
  • 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 tumor
  • Prior radiotherapy to the upper abdomen
  • Prior RFA to index lesion
  • Liver transplant
  • Tumors greater than 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 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

Sites / Locations

  • Stanford Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transarterial Chemoembolization

CyberKnife SBRT

Arm Description

Outcomes

Primary Outcome Measures

Freedom from local progression
Freedom from local progression at time T is defined as lack of local progression in the treated liver lesion in the set of patients alive and on study at time T and without distant progression up to time T.

Secondary Outcome Measures

Progression-free survival
Progression-free survival will be defined as subject alive and free from local progression, disease recurrence elsewhere in the liver, extrahepatic progression, or clinical deterioration unattributable to another underlying medical condition in the absence of clear radiographic findings of progressive disease.
Overall survival
Overall survival will be determined as a measure of time from diagnosis of initial recurrence until death from any cause.
Serum AFP levels
Serum AFP levels will be measured at specific points during the study. The 2 endpoints to be analyzed are: Initial AFP levels AFP response - the percent decrease in serum AFP levels from the initial result to the eventual nadir after therapy These endpoints will be correlated to the clinical endpoints (freedom from local progression, progression free-survival, and overall survival).
Freedom from local progression
Freedom from local progression at time T is defined as lack of local progression in the treated liver lesion in the set of patients alive and on study at time T and without distant progression up to time T.

Full Information

First Posted
March 16, 2011
Last Updated
February 16, 2012
Sponsor
Accuray Incorporated
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01318200
Brief Title
Transarterial Chemoembolization (TACE) vs. CyberKnife for Recurrent Hepatocellular Carcinoma (HCC)
Official Title
International Randomized Study of Transarterial Chemoembolization Versus CyberKnife® for Recurrent Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Withdrawn
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Accuray Incorporated
Collaborators
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the efficacy of Transarterial Chemoembolization (TACE) to CyberKnife stereotactic body radiotherapy in the treatment of patients with locally recurrent hepatocellular carcinoma (HCC) after TACE.
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. Surgical resection and/or transplantation remain the only curative options. However, more than 80% of patients present with unresectable disease. For these patients with unresectable tumors, a variety of treatment options are available, including transarterial chemoembolization (TACE), radiofrequency ablation (RFA), 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 significant 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 conventional radiotherapy as a means of intensifying local therapy, with evidence of efficacy. TACE remains the dominant mode of local therapy for unresectable HCC. However, recurrence rates are high. Because SBRT is rapidly becoming an accepted local therapy for hepatic lesions, its role in treating HCC needs to be further defined. Moreover, once patients have recurred after initial TACE, it is unclear if additional TACE will be as effective or if another mode of local therapy such as SBRT would be preferable. We propose to conduct a multicenter randomized study comparing TACE vs. SBRT using CyberKnife for locally recurrent HCC. Locally recurrent HCC will include lesions that persist, progress or recur minimum 3 months after initial TACE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Hepatocellular Carcinoma
Keywords
Primary liver cancer, Hepatocellular carcinoma, CyberKnife, Accuray, TACE, Transarterial chemoembolization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transarterial Chemoembolization
Arm Type
Active Comparator
Arm Title
CyberKnife SBRT
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Transarterial Chemoembolization
Intervention Description
Transarterial Chemoembolization will be given within 12 weeks and up to 3 staged procedures, depending on the architecture of the tumor vasculature.
Intervention Type
Radiation
Intervention Name(s)
CyberKnife SBRT
Intervention Description
Dose is 45 Gy (15 Gy in 3 fractions) or 36 Gy(12 Gy in 3 fractions). Tumors should receive the higher dose unless normal tissue constraints cannot be met.
Primary Outcome Measure Information:
Title
Freedom from local progression
Description
Freedom from local progression at time T is defined as lack of local progression in the treated liver lesion in the set of patients alive and on study at time T and without distant progression up to time T.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Progression-free survival will be defined as subject alive and free from local progression, disease recurrence elsewhere in the liver, extrahepatic progression, or clinical deterioration unattributable to another underlying medical condition in the absence of clear radiographic findings of progressive disease.
Time Frame
6, 12 and 18 months
Title
Overall survival
Description
Overall survival will be determined as a measure of time from diagnosis of initial recurrence until death from any cause.
Time Frame
Up to three years following therapy
Title
Serum AFP levels
Description
Serum AFP levels will be measured at specific points during the study. The 2 endpoints to be analyzed are: Initial AFP levels AFP response - the percent decrease in serum AFP levels from the initial result to the eventual nadir after therapy These endpoints will be correlated to the clinical endpoints (freedom from local progression, progression free-survival, and overall survival).
Time Frame
3, 6, 12 and 18 months
Title
Freedom from local progression
Description
Freedom from local progression at time T is defined as lack of local progression in the treated liver lesion in the set of patients alive and on study at time T and without distant progression up to time T.
Time Frame
6 and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 contrast liver CT A recent serum AFP must 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 7.5 cm as long as the dose constraints to normal tissue can be met. Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix I). Patients with liver disease classified as Child Pugh class A/B, if Child's class B, score must be 8 or less. Life expectancy >= 6 months Age >= 18 years old Albumin >= 2.5 g/dL Total Bilirubin <= 3 mg/dL INR <= 1.5 Creatinine <= 2.0 mg/dL Both men and women and members of all races and ethnic groups are eligible for this study 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 tumor Prior radiotherapy to the upper abdomen Prior RFA to index lesion Liver transplant Tumors greater than 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Koong, MD, PhD
Organizational Affiliation
Stanford Comprehensive Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Daniel Chang, MD
Organizational Affiliation
Stanford Comprehensive Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nishita Kothary, MD
Organizational Affiliation
Stanford Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford Comprehensive Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.cyberknife.com
Description
Information on CyberKnife
URL
http://www.accuray.com
Description
Sponsor website

Learn more about this trial

Transarterial Chemoembolization (TACE) vs. CyberKnife for Recurrent Hepatocellular Carcinoma (HCC)

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