Status:
WITHDRAWN
Stereotactic Body Radiation Therapy in Liver Cancer That Cannot be Removed by Surgery or Transplant
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01194206
Start Date
August 1 2010
End Date
March 1 2012
Last Update
April 18 2012
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