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

NCT ID: NCT01194206

Last Updated: 2012-04-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-03-31

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.

Conditions

Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

stereotactic body radiation therapy

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Other Intervention Names

SBRT; stereotactic radiation therapy; stereotactic radiotherapy

Eligibility 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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Sanabria

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Other Identifiers

NCI-2010-01883

Identifier Type: OTHER

Identifier Source: secondary_id

CASE3209

Identifier Type: -

Identifier Source: org_study_id