Carcinoma, HepatocellularSBF-HCCNCT00243841
Dose Escalation Study for Primary Hepatocellular Carcinoma
A study testing Stereotactic Body Radiation in people with Carcinoma, Hepatocellular, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Stereotactic Body Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Department of Radiation Oncology
Indianapolis, Indiana, 46202
About this study
Official title: Multi-institution Phase I/II Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma
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.
Read the 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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Stereotactic Body Radiation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body RadiationRadiation
Also called Stereotactic Body Radiation Treatments
Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Radiation Treatment Arm :A | Experimental | Patients with a score of Childs A Will receive 3 fractions of radiation over 5-10 days Receives: Radiation: Stereotactic Body Radiation |
| Radiation Treatment Arm: B | Experimental | Patients with a score of Childs B will receive 5 fractions of radiation over 2-6 weeks. Receives: Radiation: Stereotactic Body Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With DLTs
Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial.
Measured: 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
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2005 (estimated)
- Study startMay 2004
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Mark Langer, Indiana University
- Investigators
- Mark Langer, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243841
- Sponsor's protocol ID
- 0404-20 (1011003002)
- Acronym
- SBF-HCC
- Status last verified
- Nov 2018
- First submitted
- 21 Oct 2005
- Last updated
- 13 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-institution Phase I/II Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00243841
- Acronym / sponsor ID
- SBF-HCC / 0404-20 (1011003002)
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- May 2004
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 25 Oct 2005 (estimated)
- Results
- Posted 13 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation Treatment Arm :A | Experimental | Radiation: Stereotactic Body RadiationPatients with a score of Childs A Will receive 3 fractions of radiation over 5-10 days |
| Radiation Treatment Arm: B | Experimental | Radiation: Stereotactic Body RadiationPatients with a score of Childs B will receive 5 fractions of radiation over 2-6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 renal function (creatinine < 1.8 mg/dl or creatinine clearance ≥ 50 ml/min)
- Adequate bone marrow reserve:
- NOTE: Lab values must be obtained within 2 weeks prior to being registered for protocol therapy.
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body RadiationAlso: Stereotactic Body Radiation TreatmentsArm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions. | Radiation | Radiation Treatment Arm :A, Radiation Treatment Arm: B |
Primary outcome
Number of Patients With DLTs
Time frame: 6 weeks
Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial.
6 Month Local In-field Control
Time frame: 6 months
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
3 secondary outcomes
Time to In-field Failure
Time frame: up to 4 yrs
Overall Survival
Time frame: Up to 8 years
Phase II: Number of Patients With Treatment Related Grade 3 or 4 Adverse Events
Time frame: up to 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Langer, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation in people with Carcinoma, Hepatocellular, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With DLTs (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.