Stereotactic Body Radiation Therapy in Liver Cancer That Cannot be Removed by Surgery or Transplant

This study has been withdrawn prior to enrollment.
(Study being rewritten)
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01194206
First received: September 1, 2010
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue in patients with liver cancer. Giving stereotactic body radiation therapy may also increase patient eligibility for liver transplant.PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with liver cancer that cannot be removed by surgery or transplant.


Condition Intervention Phase
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Radiation: stereotactic body radiation therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Downstaging of Hepatocellular Carcinoma by Stereotactic Body Radiotherapy for Non-Resectable and Non-Transplantable Tumors: Phase 2 Study

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Rate of downstaging of stage B and C Hepatocellular Carcinoma using Stereotactic Body Radiotherapy [ Time Frame: At 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of Grade 3 or 4 adverse events associated with SBRT for liver tumors as assessed by NCI CTCAE version 4.0 [ Time Frame: Baseline, at 1 month, 3 months and 6 months ] [ Designated as safety issue: Yes ]
  • Rate of local progression as assessed by RECIST criteria [ Time Frame: Baseline, at 1 month, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Number of patients who achieve liver transplantation [ Time Frame: at 6 months after SBRT ] [ Designated as safety issue: No ]
  • Survival rate [ Time Frame: Survival will be measured from the first day of treatment on study until death of any cause. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo 3 fractions of stereotactic body radiation therapy in 3 fractions delivered within 14 days in the absence of disease progression or unacceptable toxicity.
Radiation: stereotactic body radiation therapy
At least 3 gold standard Cyberknife fiducials will be placed in the liver w/in 6 cm of the tumor for image guidance during radiation therapy. At least 1 wk will elapse between fiducial placement and tx planning simulation to allow for fiducial settling and any migration.The full radiation tx will be given ideally in 3 consecutive days. In any case there must be a minimum of 24 hrs between fractions and all 3 fractions will be delivered w/in 14 days. The dose to at least 95% of the tumor will be 37.5 Gy total in 12.5 Gy fractions.
Other Names:
  • SBRT
  • stereotactic radiation therapy
  • stereotactic radiotherapy

Detailed Description:

PRIMARY OBJECTIVES:I. To determine in patients with stage B and C Hepatocellular Carcinoma, if Stereotactic Body Radiotherapy can achieve a downstaging rate of >= 30% at 3 months.SECONDARY OBJECTIVES:I. To determine in patients with stage B and C Hepatocellular Carcinoma, if Stereotactic Body Radiotherapy can achieve a downstaging rate of >= 30% at 3 and 6 months.II. To determine the rate of Grade 3 or 4 adverse events associated with SBRT for liver tumors. III. To determine the rate of local progression after SBRT. (Based onRECIST criteria)IV. To determine the number of patients who achieve liver transplantation.OUTLINE:Patients undergo 3 fractions of stereotactic body radiation therapy delivered within 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for 2 years.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HCC is staged as Barcelona B or C (non-resectable and non-transplantable)
  • Treatment with SBRT can occur within 6 weeks of staging laparoscopy
  • Patient has a) Radiographic enhancing liver lesions on triple phase CT or MRI and b) Histological confirmation of HCC
  • Patients with clinical/imaging features of HCC but without biopsy confirmation can be initially enrolled on the protocol and undergo staging laparoscopy for biopsy confirmation with the option of having the fiducials placed in the same procedure; but if the histology is not confirmed and/or other exclusion criteria is met patient will be taken off protocol
  • Total aggregate of maximal dimension of liver tumors =< 8 cm
  • Cirrhotic patients Child Pugh Class A or B
  • Patient should be medically eligible for liver transplantation
  • Absolute neutrophil count > 1,500/ul
  • Platelets > 50,000 ul (after transfusion if required)
  • Hemoglobin greater than 10.0 g/dL
  • Total bilirubin < 2.0 mg/dL
  • AST(SGOT)/ALT(SGPT) < 2 X institutional upper limit of normal
  • Life expectancy > 12 weeks
  • ECOG performance status < 2 or Karnofsky >= 70%
  • Women of child-bearing potential must have a negative pregnancy test within 4 weeks to the start of the SBRT treatment
  • Women must not be pregnant or nursing
  • Sexually active men and women must agree to use accepted forms of birth control
  • Provision of informed consent: Patient must be able to provide verbal and written informed consent

Exclusion Criteria:

  • Patient with previous history of abdominal radiation
  • Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
  • Evidence of metastatic disease prior to staging laparoscopy
  • Evidence of main Portal Vein thrombosis
  • History of cardiac ischemia or stroke within last 6 months
  • Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppression that would constitute a contraindication to liver transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194206

Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Juan Sanabria Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01194206     History of Changes
Other Study ID Numbers: CASE3209, NCI-2010-01883
Study First Received: September 1, 2010
Last Updated: April 17, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on April 16, 2014