Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

Not Applicable

Terminated

Conditions: Hepatocellular Carcinoma

Interventions: Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Radiation: Stereotactic Body Radiation Therapy

Registration Number: NCT03812289

Lead Sponsor: OHSU Knight Cancer Institute

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 9

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (SBRT)	Quality-of-Life Assessment	Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.
Treatment (SBRT)	Questionnaire Administration	Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.
Treatment (SBRT)	Stereotactic Body Radiation Therapy	Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Who Are Transplant Eligible 1 Year Following SBRT	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 Outcome Measures

Name	Time	Method
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.	Extrahepatic progressive disease is defined as progressive disease outside of the liver.
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	Local control is defined as the absence of progressive disease within or at the planning target volume (PTV) margin.
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.	Intrahepatic progressive disease is defined as development of intrahepatic recurrent or new disease within any section of the liver, including the PTV.
Overall Survival	From first SBRT dose to time of death or 2 years after last SBRT dose (Day 739), whichever occurs first.	Reported with median survival and 95% confidence interval, if available.
Incidence of Non-classic Radiation-induced Liver Disease (RILD)	From first SBRT dose to 3 months after last SBRT dose (Day 100)	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.
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.	Measured and reported with 95% confidence interval.
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	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.