- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03812289
Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer
A Pilot Study to Assess Feasibility of Hypofractionation and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
I. 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:
I. Assess preliminary efficacy and toxicity in HCC patients with advanced cirrhosis following liver SBRT.
EXPLORATORY OBJECTIVE:
I. 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: John Minger
- Phone Number: 503-418-3247
- Email: mingerj@ohsu.edu
Study Contact Backup
- Name: Nima Nabavizadeh, MD
- Phone Number: 503-418-3685
- Email: nabaviza@ohsu.edu
Study Locations
-
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Oregon
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Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (SBRT)
Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.
|
Ancillary studies
Other Names:
Ancillary studies
Undergo SBRT
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants who are transplanted or with localized disease control per Milan criteria
Time Frame: Up to time of progression, or transplantation, or 1 year after last stereotactic body radiation therapy (SBRT) dose, whichever occurs first
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Will be reported with 95% exact confidence interval (CI).
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Up to time of progression, or transplantation, or 1 year after last stereotactic body radiation therapy (SBRT) dose, whichever occurs first
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of progressive disease within or at the planned tumor volume (PTV) margin
Time Frame: Up to time of progression, transplantation, death or 2 years after last SBRT dose, whichever occurs first
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The estimate of local control rate will be plotted using Kaplan-Meier curve and reported with median survival and 95% CI if available.
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Up to time of progression, transplantation, death or 2 years after last SBRT dose, whichever occurs first
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Incidence of intrahepatic progressive disease
Time Frame: Up to time of progression, transplantation, death or 2-years after last SBRT dose, whichever occurs first
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Will be plotted using Kaplan-Meier curve and reported with median survival and 95% CI if available.
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Up to time of progression, transplantation, death or 2-years after last SBRT dose, whichever occurs first
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Incidence of extrahepatic progressive disease
Time Frame: Up to time of progression, transplantation, death or 2-years after last SBRT dose, whichever occurs first
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Up to time of progression, transplantation, death or 2-years after last SBRT dose, whichever occurs first
|
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Proportion of participants that proceed to transplantation
Time Frame: Up to time of progression, transplantation, death or 2-years after last SBRT dose, whichever occurs first
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Will be measured and reported with 95% CI.
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Up to time of progression, transplantation, death or 2-years after last SBRT dose, whichever occurs first
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Overall survival
Time Frame: Up to time of death or 2 years after last SBRT dose
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Will be plotted using Kaplan-Meier curve and reported with median survival and 95% CI if available.
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Up to time of death or 2 years after last SBRT dose
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Incidence of non-classic radiation-induced liver disease (RILD) defined as grade 4 aspartate aminotransferase or alanine aminotransferase elevation, or an increase in Child Pugh (CP) score of >= 2 within 1 week to 3 months after completing SBRT
Time Frame: Up to 3 months after last SBRT dose
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Will be estimated along with an exact CI using the safety analysis set.
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Up to 3 months after last SBRT dose
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Incidence of liver toxicity assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0
Time Frame: Within 1 week to 3 months after completing SBRT
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Will be estimated along with an exact CI using the safety analysis set.
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Within 1 week to 3 months after completing SBRT
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life (QoL) score using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 questionnaire
Time Frame: From baseline to death or 2 years after the last SBRT dose, whichever occurs first
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Summary of QoLs and its change over time will be presented graphically using box plot and spaghetti plot, in addition to a summary table of QoL over time.
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From baseline to death or 2 years after the last SBRT dose, whichever occurs first
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Change in QoL scores for Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire
Time Frame: From baseline to death or 2 years after the last SBRT dose, whichever occurs first
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Summary of QoLs and its change over time will be presented graphically using box plot and spaghetti plot, in addition to a summary table of QoL over time.
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From baseline to death or 2 years after the last SBRT dose, whichever occurs first
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Proportion of histopathologic changes in irradiated tumor sites relative to uninvolved liver tissue
Time Frame: At transplantation
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Descriptive statistical analysis, utilizing the efficacy analysis set, will be used to measure the proportion of histopathologic changes in irradiated tumor sites relative to uninvolved liver tissue will be measured.
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At transplantation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nima Nabavizadeh, MD, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00018810 (Other Identifier: OHSU Knight Cancer Institute)
- NCI-2018-02864 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- SOL-18142-L
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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