Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Indiana University
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00243841
First received: October 21, 2005
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Carcinoma, Hepatocellular
Radiation: Stereotactic Body Radiation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • To determine 6 month local in-field control of this patient population [ Time Frame: 2 years from enrollment completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the in-field treatment response and failure rate of this therapy [ Time Frame: Post Treatment ] [ Designated as safety issue: Yes ]
  • To evaluate the dose limiting toxicity (DLT) of this therapy [ Time Frame: Lifetime ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2004
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243841

Contacts
Contact: Higinia Cardenes, MD PhD 317-944-2525 hcardene@iupui.edu
Contact: Jill DeLuca, CCRp 317-944-1189 jdelucca@iupui.edu

Locations
United States, Indiana
Indiana University Department of Radiation Oncology Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Higinia Cardenes, MD PhD    317-944-2525    hcardene@iupui.edu   
Principal Investigator: Higinia Cardenes, MD PhD         
Sponsors and Collaborators
Indiana University School of Medicine
University of Colorado, Denver
Investigators
Principal Investigator: Higinia Cardenes Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00243841     History of Changes
Other Study ID Numbers: 0404-20
Study First Received: October 21, 2005
Last Updated: January 10, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014