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The purpose of this study is to determine the maximum tolerated dose of limited fractions of large dose radiation in an effort to achieve a biologically potent cancer therapy in selected patients with primary hepatocellular carcinoma.
Full description
Despite recent advances in early detection and diagnosis, only 30-40% of patients with hepatocellular carcinoma may benefit from radical therapies. Liver transplantation offers the best chance for cure. Surgical resection has been the only other potentially curative option, but the majority of patients are not candidates for resection. This reflects the usual comorbidity of severe underlying liver disease that either precludes surgery or makes the surgical approach extremely dangerous.
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Inclusion criteria
Evaluation by the Surgery and/or Liver Transplant Team has been performed and the patient is not considered a candidate for either "standard" therapy to target area (upper abdomen)
Adequate liver function defined as:
Adequate renal function (creatinine < 1.8 mg/dl or creatinine clearance ≥ 50 ml/min)
Adequate bone marrow reserve:
NOTE: Lab values must be obtained within 2 weeks prior to being registered for protocol therapy.
Exclusion criteria
No history of systemic lupus erythematous, rheumatoid arthritis, systemic sclerosis or scleroderma
No chemotherapy within 14 days before radiotherapy (chemotherapy may cause transient hepatitis with hepatomegaly)
No subsequent chemotherapy planned within 2 weeks of radiotherapy
No active liver infection
No acute Hepatitis. Definition of active disease:
Hepatitis A: Acute hepatitis determined by presence of Anti-HAV- IgM
Hepatitis B:
Primary purpose
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Interventional model
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77 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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