Dose Escalation Study for Primary Hepatocellular Carcinoma (SBF-HCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00243841
Recruitment Status : Completed
First Posted : October 25, 2005
Last Update Posted : March 22, 2017
University of Colorado, Denver
Information provided by (Responsible Party):
Mark Langer, Indiana University

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 primary hepatocellular carcinoma.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Radiation: Stereotactic Body Radiation Not Applicable

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-institution Phase I/II Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma
Study Start Date : May 2004
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Arm Intervention/treatment
Experimental: Radiation Treatment Arm :A
Patients with a score of Childs A Will receive 3 fractions of radiation over 5-10 days
Radiation: Stereotactic Body Radiation
Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.
Other Name: Stereotactic Body Radiation Treatments

Experimental: Radiation Treatment Arm: B
Patients with a score of Childs B will receive 5 fractions of radiation over 2-6 weeks.
Radiation: Stereotactic Body Radiation
Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.
Other Name: Stereotactic Body Radiation Treatments

Primary Outcome Measures :
  1. To determine 6 month local in-field control of this patient population [ Time Frame: 2 years from enrollment completion ]

Secondary Outcome Measures :
  1. To evaluate the in-field treatment response and failure rate of this therapy [ Time Frame: Post Treatment ]
  2. To evaluate the dose limiting toxicity (DLT) of this therapy [ Time Frame: Lifetime ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00243841

United States, Indiana
Indiana University Department of Radiation Oncology
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
University of Colorado, Denver
Principal Investigator: Mark Langer, MD Indiana University School of Medicine

Responsible Party: Mark Langer, Professor of Clinical Radiation Oncology, Indiana University Identifier: NCT00243841     History of Changes
Other Study ID Numbers: 0404-20
First Posted: October 25, 2005    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases