This trial is active, not recruiting.

Condition carcinoma, hepatocellular
Treatment stereotactic body radiation
Phase phase 1/phase 2
Sponsor Indiana University School of Medicine
Collaborator University of Colorado, Denver
Start date May 2004
End date December 2016
Trial size 60 participants
Trial identifier NCT00243841, 0404-20


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Patients with a score of Childs A Will receive 3 fractions of radiation over 5-10 days
stereotactic body radiation Stereotactic Body Radiation Treatments
Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.
Patients with a score of Childs B will receive 5 fractions of radiation over 2-6 weeks.
stereotactic body radiation Stereotactic Body Radiation Treatments
Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.

Primary Outcomes

To determine 6 month local in-field control of this patient population
time frame: 2 years from enrollment completion

Secondary Outcomes

To evaluate the in-field treatment response and failure rate of this therapy
time frame: Post Treatment
To evaluate the dose limiting toxicity (DLT) of this therapy
time frame: Lifetime

Eligibility Criteria

Male or female participants at least 18 years old.

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: - 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 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: 1. HBsAg (HB surface Antigen): present in patients with acute and chronic hepatitis 2. HBV DNA present in patients with active viral replication in amounts greater than 100,000 copies 3. HBeAg is present in wild type HBV infection and suggests active replication 4. Anti-HBs: Antibody against HBsAg appears after HBV infections and confers immunity 5. 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 6. Anti-HBc-IgG: is present in chronic disease

Additional Information

Official title Multi-institution Phase I/II Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma
Principal investigator Mark Langer, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Indiana University.