An interventional study of Stereotactic Body Radiation in Carcinoma, Hepatocellular, sponsored by Indiana University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-13.
Sponsored by Indiana University School of Medicine · Not applicable, Interventional, and Treatment
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.
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.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's enrollment of 77 is above the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Adequate bone marrow reserve:
NOTE: Lab values must be obtained within 2 weeks prior to being registered for protocol therapy.
Exclusion Criteria:
No acute Hepatitis. Definition of active disease:
:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a score of Childs A Will receive 3 fractions of radiation over 5-10 days
Radiation: Stereotactic Body Radiation
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.
Also known as: Stereotactic Body Radiation Treatments
Number of Patients With DLTs
Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial.
Time frame: 6 weeks
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
Time frame: 6 months
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.
Time frame: up to 4 yrs
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.
Time frame: Up to 8 years
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.
Time frame: up to 4 years
| Milestone | Phase I: 36 Gy | Phase I: 42 Gy | Phase I: 40 Gy | Phase I: 48 Gy | Phase II Childs A | Phase II Childs B |
|---|---|---|---|---|---|---|
| Started | 3 | 6 | 5 | 3 | 39 | 21 |
| Completed | 3 | 6 | 4 | 3 | 39 | 19 |
| Not completed | 0 | 0 | 1 | 0 | 0 | 2 |
| Withdrew: Physician decision | 0 | 0 | 1 | 0 | 0 | 2 |
Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial.
| Participants | Phase I: 36 Gy | Phase I: 42 Gy | Phase I: 40 Gy | Phase I: 48 Gy |
|---|---|---|---|---|
| Number of Patients With DLTs | 0 | 2 | 1 | 0 |
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
| percentage of participants | Phase II Childs A | Phase II Childs B |
|---|---|---|
| 6 Month Local In-field Control | 92.3 (79.1 to 98.4) | 87.5 (61.7 to 98.5) |
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.
| months | Phase II Childs A | Phase II Childs B |
|---|---|---|
| Time to In-field Failure | NA (NA to NA) | 32.2 (32.2 to NA) |
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.
| months | Radiation Treatment Arm :A | Radiation Treatment Arm: B |
|---|---|---|
| Overall Survival | 50.43 (30.88 to 68.59) | 21.40 (10.45 to NA) |
Number of unique patients who had grade 3 or 4 adverse events that were possibly, probably or definitely related to study treatment.
| Participants | Phase II Childs A | Phase II Childs B |
|---|---|---|
| Phase II: Number of Patients With Treatment Related Grade 3 or 4 Adverse Events | 5 | 9 |
Collected over up to 4 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase I: 36 Gy | 3/3 (100%) | 1/3 (33.3%) | 3/3 (100%) |
| Phase I: 42 Gy | 4/6 (66.7%) | 1/6 (16.7%) | 6/6 (100%) |
| Phase I: 40 Gy | 4/5 (80%) | 1/5 (20%) | 5/5 (100%) |
| Phase I: 48 Gy | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) |
| Phase II Childs A | 19/39 (48.7%) | 1/39 (2.6%) | 39/39 (100%) |
| Phase II Childs B | 13/21 (61.9%) | 1/21 (4.8%) | 21/21 (100%) |
| Event | Phase I: 36 Gy | Phase I: 42 Gy | Phase I: 40 Gy | Phase I: 48 Gy | Phase II Childs A | Phase II Childs B |
|---|---|---|---|---|---|---|
| Leukocytes (total WBC)Investigations | 0/3 | 0/6 | 0/5 | 1/3 | 0/39 | 0/21 |
| PlateletsInvestigations | 0/3 | 0/6 | 1/5 | 1/3 | 0/39 | 0/21 |
| Cardiac arhythmia - otherCardiac disorders | 0/3 | 0/6 | 0/5 | 1/3 | 0/39 | 0/21 |
| Gastrointestinal - otherGastrointestinal disorders | 0/3 | 0/6 | 0/5 | 1/3 | 0/39 | 0/21 |
| Albumin, serum-low (hypoalbuminemia)Metabolism and nutrition disorders | 0/3 | 0/6 | 1/5 | 1/3 | 0/39 | 0/21 |
| AST, SGOT (serum glutamic oxaloacetic transaminase)Metabolism and nutrition disorders | 0/3 | 0/6 | 1/5 | 1/3 | 0/39 | 0/21 |
| ConfusionNervous system disorders | 1/3 | 0/6 | 0/5 | 0/3 | 0/39 | 0/21 |
| HemoglobinInvestigations | 0/3 | 0/6 | 1/5 | 0/3 | 1/39 | 0/21 |
| ALT, SGPT (serum glutamic pyruvic transaminase)Metabolism and nutrition disorders | 0/3 | 0/6 | 1/5 | 0/3 | 0/39 | 0/21 |
| Bilirubin (hyperbilirubinemia)Investigations | 0/3 | 0/6 | 1/5 | 0/3 | 0/39 | 0/21 |
| Event | Phase I: 36 Gy | Phase I: 42 Gy | Phase I: 40 Gy | Phase I: 48 Gy | Phase II Childs A | Phase II Childs B |
|---|---|---|---|---|---|---|
| PlateletsInvestigations | 1/3 | 4/6 | 4/5 | 2/3 | 35/39 | 21/21 |
| INR (international normalized ratio of prothrobin time)Investigations | 3/3 | 3/6 | 5/5 | 2/3 | 20/39 | 18/21 |
| Albumin, Serum-low(hypoalbuminemia)Metabolism and nutrition disorders | 2/3 | 6/6 | 5/5 | 1/3 | 30/39 | 21/21 |
| Alkaline PhosphateMetabolism and nutrition disorders | 0/3 | 4/6 | 4/5 | 3/3 | 21/39 | 15/21 |
| AST, SGOTMetabolism and nutrition disorders | 2/3 | 5/6 | 5/5 | 3/3 | 38/39 | 21/21 |
| BilirubinInvestigations | 3/3 | 5/6 | 5/5 | 3/3 | 33/39 | 21/21 |
| GGTInvestigations | 3/3 | 5/6 | 3/5 | 3/3 | 35/39 | 18/21 |
| HemoglobinInvestigations | 0/3 | 5/6 | 4/5 | 2/3 | 29/39 | 15/21 |
| Leukocytes (total WBC)Investigations | 1/3 | 3/6 | 2/5 | 2/3 | 31/39 | 16/21 |
| ALT, SGPTMetabolism and nutrition disorders | 2/3 | 1/6 | 3/5 | 2/3 | 29/39 | 14/21 |
| Age, Categorical(Participants) | Phase I | Phase II Childs A | Phase II Childs B | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 27 | 17 | 54 |
| >=65 years | 7 | 12 | 4 | 23 |
| Age, Continuous(years) | Phase I | Phase II Childs A | Phase II Childs B | Total |
|---|---|---|---|---|
| Mean | 60.8 ± 9.76 | 60.9 ± 10.62 | 58.5 ± 7.55 | 60.2 ± 9.6 |
| Sex: Female, Male(Participants) | Phase I | Phase II Childs A | Phase II Childs B | Total |
|---|---|---|---|---|
| Female | 1 | 11 | 4 | 16 |
| Male | 16 | 28 | 17 | 61 |
| Ethnicity (NIH/OMB)(Participants) | Phase I | Phase II Childs A | Phase II Childs B | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 16 | 38 | 20 | 74 |
| Unknown or Not Reported | 1 | 1 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Phase I | Phase II Childs A | Phase II Childs B | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 7 | 2 | 11 |
| White | 15 | 30 | 19 | 64 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
The record gives a start of May 2004, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2018, 1 year 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Indiana University School of Medicine