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

Phase 2

Withdrawn

• Conditions: Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer
• Interventions: Radiation: stereotactic body radiation therapy

• Registration Number: NCT01194206
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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.

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-17
• Last Update Posted: 2012-04-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	stereotactic body radiation therapy	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.

Primary Outcome Measures

Name	Time	Method
Rate of downstaging of stage B and C Hepatocellular Carcinoma using Stereotactic Body Radiotherapy	At 3 months

Secondary Outcome Measures

Name	Time	Method
Rate of Grade 3 or 4 adverse events associated with SBRT for liver tumors as assessed by NCI CTCAE version 4.0	Baseline, at 1 month, 3 months and 6 months
Rate of local progression as assessed by RECIST criteria	Baseline, at 1 month, 3 months and 6 months
Number of patients who achieve liver transplantation	at 6 months after SBRT
Survival rate	Survival will be measured from the first day of treatment on study until death of any cause.