Status:
COMPLETED
Dose Escalation Study for Primary Hepatocellular Carcinoma
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed 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 cur...
Eligibility Criteria
Inclusion
- 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:
- total bilirubin \< 3mg/dl, albumin \> 2.5 g/dl
- normal PT/PTT unless on anticoagulants
- mild elevation of liver enzymes acceptable (must be less than three times upper limit of normal)
- Adequate renal function (creatinine \< 1.8 mg/dl or creatinine clearance ≥ 50 ml/min)
- Adequate bone marrow reserve:
- ANC count ≥ 1500 mm3
- Platelets ≥ 50,000/mm3
- Hemoglobin \> 9 g/dL
- NOTE: Lab values must be obtained within 2 weeks prior to being registered for protocol therapy.
Exclusion
- 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:
- HBsAg (HB surface Antigen): present in patients with acute and chronic hepatitis
- HBV DNA present in patients with active viral replication in amounts greater than 100,000 copies
- HBeAg is present in wild type HBV infection and suggests active replication
- Anti-HBs: Antibody against HBsAg appears after HBV infections and confers immunity
- Anti-HBc-IgM: Antibody against HBcAg, fraction IgM, present in acute infection and often could be detected during periods of high viral replication in chronic disease
- Anti-HBc-IgG: is present in chronic disease
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00243841
Start Date
May 1 2004
End Date
December 31 2016
Last Update
December 13 2018
Active Locations (1)
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1
Indiana University Department of Radiation Oncology
Indianapolis, Indiana, United States, 46202