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Completed

NCT Number: NCT00243841

Dose Escalation Study for Primary Hepatocellular Carcinoma

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Department of Radiation Oncology

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

Stereotactic Body Radiation

Radiation

Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.

Other names: Stereotactic Body Radiation Treatments

Primary outcomes

  1. Number of Patients With DLTs

    Time frame: 6 weeks

    Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial.

  2. 6 Month Local In-field Control

    Time frame: 6 months

    Percent of patients and the 95% Binomial Confidence interval who were free of in-field progression at 6 months following treatment for the patients in Phase II

Secondary outcomes

  1. Time to In-field Failure

    Time frame: up to 4 yrs

    Kaplan-Meier Analyses will be used to calculate the median and 95% Confidence Interval for the time until in-field failure. This will be calculated from the time of treatment until the time of in-field failure. If a patient did not have in-field failure, the patient will be censored at their last evaluation date.

  2. Overall Survival

    Time frame: Up to 8 years

    Kaplan-Meier Analysis will be used to calculate the median and 95% CI for overall survival. This will be calculated from the time of treatment until death. If a patient did not die, the patient will be censored at their last known alive date.

  3. Phase II: Number of Patients With Treatment Related Grade 3 or 4 Adverse Events

    Time frame: up to 4 years

    Number of unique patients who had grade 3 or 4 adverse events that were possibly, probably or definitely related to study treatment.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • University of Colorado, Denver

Registry information

Official study title

Multi-institution Phase I/II Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma

Acronym: SBF-HCC

Important dates

Study start
2004
Primary completion
2016
Study completion
2016
First posted
Oct 25, 2005
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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