Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer
Study Details
Study Description
Brief 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. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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. |
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants who are transplanted or with localized disease control per Milan criteria [Up to time of progression, or transplantation, or 1 year after last stereotactic body radiation therapy (SBRT) dose, whichever occurs first]
Will be reported with 95% exact confidence interval (CI).
Secondary Outcome Measures
- Incidence of progressive disease within or at the planned tumor volume (PTV) margin [Up to time of progression, transplantation, death or 2 years after last SBRT dose, whichever occurs first]
The estimate of local control rate will be plotted using Kaplan-Meier curve and reported with median survival and 95% CI if available.
- Incidence of intrahepatic progressive disease [Up to time of progression, transplantation, death or 2-years after last SBRT dose, whichever occurs first]
Will be plotted using Kaplan-Meier curve and reported with median survival and 95% CI if available.
- Incidence of extrahepatic progressive disease [Up to time of progression, transplantation, death or 2-years after last SBRT dose, whichever occurs first]
- Proportion of participants that proceed to transplantation [Up to time of progression, transplantation, death or 2-years after last SBRT dose, whichever occurs first]
Will be measured and reported with 95% CI.
- Overall survival [Up to time of death or 2 years after last SBRT dose]
Will be plotted using Kaplan-Meier curve and reported with median survival and 95% CI if available.
- 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 [Up to 3 months after last SBRT dose]
Will be estimated along with an exact CI using the safety analysis set.
- Incidence of liver toxicity assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 [Within 1 week to 3 months after completing SBRT]
Will be estimated along with an exact CI using the safety analysis set.
Other Outcome Measures
- Change in quality of life (QoL) score using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 questionnaire [From baseline to death or 2 years after the last SBRT dose, whichever occurs first]
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.
- Change in QoL scores for Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire [From baseline to death or 2 years after the last SBRT dose, whichever occurs first]
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.
- Proportion of histopathologic changes in irradiated tumor sites relative to uninvolved liver tissue [At transplantation]
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.
Eligibility Criteria
Criteria
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
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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
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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
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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
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Complete obstruction of portal venous flow to the segment of liver that includes the target lesion
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Prior radiotherapy to the upper abdomen or radioembolization of the liver, or prior thermal ablation to the target lesion
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For fiducial marker placement:
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Have a gold allergy
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Any coagulopathy preventing safe fiducial placement
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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
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OHSU Knight Cancer Institute | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- OHSU Knight Cancer Institute
- Radiation Oncology Institute
- Oregon Health and Science University
Investigators
- Principal Investigator: Nima Nabavizadeh, MD, OHSU Knight Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00018810
- NCI-2018-02864
- SOL-18142-L
- STUDY00018810