Hepatocellular CarcinomaNCT03812289
Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer
A study testing Quality-of-Life Assessment, Questionnaire Administration and Stereotactic Body Radiation Therapy in people with Hepatocellular Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This trial studies how well stereotactic body radiation therapy works in treating patients with liver cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2019to 11 Jan 2024
- 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
- Ability to understand and the willingness to sign a written informed consent document
- Must be listed or recommended to be listed for orthotopic liver transplantation at the participating institution
- Have a Child-Pugh (CP) score >= B8
- Eastern Clinical Oncology Group (ECOG) performance status =< 2, or Karnofsky performance scale > 60
- Must have a life expectancy > 12 weeks
- Safe radiation treatment planning parameters that adhere to all organs at risk constraints per section 5.1 of the protocol. If normal organs at risk constraints (including at least 700cc of uninvolved liver) are unable to be met at the lowest dose modification (30 Gy in 5 fractions), the patient is deemed ineligible for SBRT and deemed a screen failure
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- Except for prior radiotherapy or radioembolization, other prior therapies to previously treated lesions, are permitted
- People of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of SBRT. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year without an alternative medical cause
- Note: Abstinence is acceptable if this is the preferred contraception for the participant
- No other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer. Stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five years
Who cannot join
- Participants have any one of the following liver tumor characteristics:
- Have > 5 liver tumors, or
- Maximal diameter > 5 cm
- Complete obstruction of portal venous flow to the segment of liver that includes the target lesion
- Prior radiotherapy to the upper abdomen or radioembolization of the liver, or prior thermal ablation to the target lesion
- For fiducial marker placement:
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- Have a gold allergy
- Any coagulopathy preventing safe fiducial placement
- Contraindication to both contrast enhanced magnetic resonance imaging (MRI) and contrast enhanced computed tomography (CT) (i.e. unable to undergo follow-up imaging or SBRT treatment planning)
- Participation in another concurrent treatment protocol
- Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: A Pilot Study to Assess Feasibility of Hypofractionation and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation
This trial studies how well stereotactic body radiation therapy works in treating patients with liver cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Read the detailed description
PRIMARY OBJECTIVE:
- Assess the use of stereotactic body radiation therapy (SBRT) in hepatocellular carcinoma (HCC) patients with advanced liver cirrhosis as a feasible approach to providing localized disease control that adequately suffices liver transplant eligibility criteria.
SECONDARY OBJECTIVE:
- Assess preliminary efficacy and toxicity in HCC patients with advanced cirrhosis following liver SBRT.
EXPLORATORY OBJECTIVE:
- Assess qualify of life in HCC patients with advanced cirrhosis following liver SBRT.
OUTLINE:
Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 weeks, then every 3 months for up to 2 years.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Body Radiation Therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SBRT) | Experimental | Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Are Transplant Eligible 1 Year Following SBRT
"Transplant eligible" means transplanted within 1 year or having localized disease control that meets Milan criteria at 1-year post-SBRT. Reported with 95% exact confidence interval.
Measured: From first SBRT dose to time of disease progression, transplantation, or 1 year after last SBRT dose (Day 374), whichever occurs first
Secondary outcomes (7)
Localized Control Rate
Local control is defined as the absence of progressive disease within or at the planning target volume (PTV) margin.
Measured: From first SBRT dose to time of disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first
Incidence of Intrahepatic Progressive Disease
Intrahepatic progressive disease is defined as development of intrahepatic recurrent or new disease within any section of the liver, including the PTV.
Measured: From first SBRT dose to time of intrahepatic disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.
Incidence of Extrahepatic Progressive Disease
Extrahepatic progressive disease is defined as progressive disease outside of the liver.
Measured: From first dose of SBRT to time of extrahepatic disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.
Proportion of Participants That Proceed to Transplantation
Measured and reported with 95% confidence interval.
Measured: From first SBRT dose to time of disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.
Overall Survival
Reported with median survival and 95% confidence interval, if available.
Measured: From first SBRT dose to time of death or 2 years after last SBRT dose (Day 739), whichever occurs first.
Incidence of Non-classic Radiation-induced Liver Disease (RILD)
Non-classic RILD is defined as grade 4 aspartate aminotransferase or alanine aminotransferase elevation, or an increase in Child-Pugh score of ≥ 2 within 1 week to 3 months after completing SBRT. Will be estimated along with an exact confidence interval.
Measured: From first SBRT dose to 3 months after last SBRT dose (Day 100)
Incidence of Liver Toxicity Within 1 Week to 3 Months After SBRT.
Liver toxicity is assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be estimated along with an exact confidence interval.
Measured: From 1 week (Day 16) to 3 months (Day 100) after completing SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start7 Feb 2019
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Why it stopped: PI decision
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 Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Radiation Oncology Institute, Oregon Health and Science University
- Responsible party
- Principal investigator, Nima Nabavizadeh, OHSU Knight Cancer Institute
- Investigators
- Nima Nabavizadeh, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812289
- Sponsor's protocol ID
- STUDY00018810
- Other IDs
- NCI-2018-02864, SOL-18142-L, STUDY00018810
- Status last verified
- Feb 2025
- First submitted
- 18 Jan 2019
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Feasibility of Hypofractionation and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation
- ClinicalTrials.gov ID
- NCT03812289
- Acronym / sponsor ID
- STUDY00018810
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI decision
- Enrolment
- 9 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Radiation Oncology Institute, Oregon Health and Science University
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies how well stereotactic body radiation therapy works in treating patients with liver cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Detailed description
PRIMARY OBJECTIVE:
- Assess the use of stereotactic body radiation therapy (SBRT) in hepatocellular carcinoma (HCC) patients with advanced liver cirrhosis as a feasible approach to providing localized disease control that adequately suffices liver transplant eligibility criteria.
SECONDARY OBJECTIVE:
- Assess preliminary efficacy and toxicity in HCC patients with advanced cirrhosis following liver SBRT.
EXPLORATORY OBJECTIVE:
- Assess qualify of life in HCC patients with advanced cirrhosis following liver SBRT.
OUTLINE:
Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 weeks, then every 3 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SBRT) | Experimental | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Stereotactic Body Radiation TherapyPatients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to understand and the willingness to sign a written informed consent document
- Must be listed or recommended to be listed for orthotopic liver transplantation at the participating institution
- Have a Child-Pugh (CP) score >= B8
- Eastern Clinical Oncology Group (ECOG) performance status =< 2, or Karnofsky performance scale > 60
- Must have a life expectancy > 12 weeks
Key exclusion criteria (12 listed)
- Participants have any one of the following liver tumor characteristics:
- Complete obstruction of portal venous flow to the segment of liver that includes the target lesion
- Prior radiotherapy to the upper abdomen or radioembolization of the liver, or prior thermal ablation to the target lesion
- For fiducial marker placement:
- Contraindication to both contrast enhanced magnetic resonance imaging (MRI) and contrast enhanced computed tomography (CT) (i.e. unable to undergo follow-up imaging or SBRT treatment planning)
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 |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (SBRT) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (SBRT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Treatment (SBRT) |
Primary outcome
Proportion of Participants Who Are Transplant Eligible 1 Year Following SBRT
Time frame: From first SBRT dose to time of disease progression, transplantation, or 1 year after last SBRT dose (Day 374), whichever occurs first
"Transplant eligible" means transplanted within 1 year or having localized disease control that meets Milan criteria at 1-year post-SBRT. Reported with 95% exact confidence interval.
7 secondary outcomes
Localized Control Rate
Time frame: From first SBRT dose to time of disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first
Incidence of Intrahepatic Progressive Disease
Time frame: From first SBRT dose to time of intrahepatic disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.
Incidence of Extrahepatic Progressive Disease
Time frame: From first dose of SBRT to time of extrahepatic disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.
Proportion of Participants That Proceed to Transplantation
Time frame: From first SBRT dose to time of disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.
Overall Survival
Time frame: From first SBRT dose to time of death or 2 years after last SBRT dose (Day 739), whichever occurs first.
Incidence of Non-classic Radiation-induced Liver Disease (RILD)
Time frame: From first SBRT dose to 3 months after last SBRT dose (Day 100)
Incidence of Liver Toxicity Within 1 Week to 3 Months After SBRT.
Time frame: From 1 week (Day 16) to 3 months (Day 100) after completing SBRT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- 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.
Nima Nabavizadeh, MD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality-of-Life Assessment, Questionnaire Administration and Stereotactic Body Radiation Therapy in people with Hepatocellular Carcinoma, run by OHSU Knight Cancer Institute 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 12 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: stopped early, as of the sponsor's last update on 7 Mar 2025. 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 7 Mar 2025). 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?
Proportion of Participants Who Are Transplant Eligible 1 Year Following SBRT (time frame: From first SBRT dose to time of disease progression, transplantation, or 1 year after last SBRT dose (Day 374), whichever occurs first). 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 7 Mar 2025.