Dose Escalation Study for Primary Hepatocellular Carcinoma

Carcinoma, Hepatocellular Clinical Trial

— SBF-HCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243841
• Other study ID #: 0404-20 (1011003002)
• Status: Completed
• Phase: N/A
• Start date: May 2004
• Est. completion date: December 31, 2016

Study information

• Verified date: November 2018
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Radiation:
• Stereotactic Body Radiation
Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.

Locations

Country	Name	City	State
United States	Indiana University Department of Radiation Oncology	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With DLTs	Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial.	6 weeks
Primary	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	6 months
Secondary	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.	up to 4 yrs
Secondary	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.	Up to 8 years
Secondary	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.	up to 4 years