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

Primary Purpose

Carcinoma, Hepatocellular

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University Department of Radiation Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Radiation Treatment Arm :A

Radiation Treatment Arm: B

Arm Description

Patients with a score of Childs A Will receive 3 fractions of radiation over 5-10 days

Patients with a score of Childs B will receive 5 fractions of radiation over 2-6 weeks.

Outcomes

Primary Outcome Measures

Number of Patients With DLTs
Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial.
6 Month Local In-field Control
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 Outcome Measures

Time to In-field Failure
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.
Overall Survival
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.
Phase II: Number of Patients With Treatment Related Grade 3 or 4 Adverse Events
Number of unique patients who had grade 3 or 4 adverse events that were possibly, probably or definitely related to study treatment.

Full Information

First Posted
October 21, 2005
Last Updated
November 15, 2018
Sponsor
Indiana University School of Medicine
Collaborators
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT00243841
Brief Title
Dose Escalation Study for Primary Hepatocellular Carcinoma
Acronym
SBF-HCC
Official Title
Multi-institution Phase I/II Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University School of Medicine
Collaborators
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation Treatment Arm :A
Arm Type
Experimental
Arm Description
Patients with a score of Childs A Will receive 3 fractions of radiation over 5-10 days
Arm Title
Radiation Treatment Arm: B
Arm Type
Experimental
Arm Description
Patients with a score of Childs B will receive 5 fractions of radiation over 2-6 weeks.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation
Other Intervention Name(s)
Stereotactic Body Radiation Treatments
Intervention Description
Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.
Primary Outcome Measure Information:
Title
Number of Patients With DLTs
Description
Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial.
Time Frame
6 weeks
Title
6 Month Local In-field Control
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time to In-field Failure
Description
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.
Time Frame
up to 4 yrs
Title
Overall Survival
Description
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.
Time Frame
Up to 8 years
Title
Phase II: Number of Patients With Treatment Related Grade 3 or 4 Adverse Events
Description
Number of unique patients who had grade 3 or 4 adverse events that were possibly, probably or definitely related to study treatment.
Time Frame
up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Langer, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Department of Radiation Oncology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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Dose Escalation Study for Primary Hepatocellular Carcinoma

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