A Pilot Study to Assess Feasibility of Hypofractionation and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- OHSU Knight Cancer Institute
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Proportion of Participants Who Are Transplant Eligible 1 Year Following SBRT
- Status
- Terminated
- Last Updated
- last year
Overview
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.
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.
Investigators
Nima Nabavizadeh
Principal Investigator
OHSU Knight Cancer Institute
Eligibility 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
- •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
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Incidence of Extrahepatic Progressive Disease(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.)
- Localized Control Rate(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(From first SBRT dose to time of intrahepatic disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.)
- Overall Survival(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)(From first SBRT dose to 3 months after last SBRT dose (Day 100))
- Proportion of Participants That Proceed to Transplantation(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 Liver Toxicity Within 1 Week to 3 Months After SBRT.(From 1 week (Day 16) to 3 months (Day 100) after completing SBRT)