Dose Escalation Study for Primary Hepatocellular Carcinoma

Completed · Not applicable

Conditions studied: Carcinoma, Hepatocellular

In brief

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.

Key facts

Study ID

NCT00243841

Run by

Indiana University

People needed

77

Starts

2004-05-01

Expected to finish

2016-12-31

Last updated by the study team

2018-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Indiana University Department of Radiation Oncology — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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