N/A
N=77
Dose Escalation Study for Primary Hepatocellular Carcinoma
Carcinoma, Hepatocellular
Bottom Line
View on ClinicalTrials.gov: NCT00243841 ↗Enrolled (actual)
77
Serious AEs
7.8%
Results posted
Dec 2018
Primary outcome: Primary: Number of Patients With DLTs — 0; 2; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stereotactic Body Radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With DLTs |
0; 2; 1; 0 | — |
| PRIMARY 6 Month Local In-field Control |
92.3; 87.5 | — |
| SECONDARY Time to In-field Failure |
NA; 32.2 | — |
| SECONDARY Overall Survival |
50.43; 21.40 | — |
| SECONDARY Phase II: Number of Patients With Treatment Related Grade 3 or 4 Adverse Events |
5; 9 | — |
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.
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 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 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
Data sourced from ClinicalTrials.gov (NCT00243841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.