Clinical trial NCT03812289: Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer
Official title: A Pilot Study to Assess Feasibility of Hypofractionation and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Radiation Oncology Institute
name: Oregon Health and Science University
First posted: 2019-01-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Proportion of Participants Who Are Transplant Eligible 1 Year Following SBRT
timeFrame: From first SBRT dose to time of disease progression, transplantation, or 1 year after last SBRT dose (Day 374), whichever occurs first
Secondary outcomes:
measure: Localized Control Rate
timeFrame: From first SBRT dose to time of disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first
measure: Incidence of Intrahepatic Progressive Disease
timeFrame: From first SBRT dose to time of intrahepatic disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.
measure: Incidence of Extrahepatic Progressive Disease
timeFrame: 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.
measure: Proportion of Participants That Proceed to Transplantation
timeFrame: From first SBRT dose to time of disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.
measure: Overall Survival
timeFrame: From first SBRT dose to time of death or 2 years after last SBRT dose (Day 739), whichever occurs first.
measure: Incidence of Non-classic Radiation-induced Liver Disease (RILD)
timeFrame: From first SBRT dose to 3 months after last SBRT dose (Day 100)
measure: Incidence of Liver Toxicity Within 1 Week to 3 Months After SBRT.
timeFrame: From 1 week (Day 16) to 3 months (Day 100) after completing SBRT
Other outcomes:
measure: Quality of Life (QoL) Scores for European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Questionnaire
timeFrame: From screening to death or 2 years after last SBRT dose, whichever occurs first.
measure: QoL Scores for Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Questionnaire
timeFrame: From screening to death or 2 years after last SBRT dose, whichever occurs first.
measure: Proportion With Histopathologic Changes in Irradiated Tumor Sites Relative to Uninvolved Liver Tissue
timeFrame: At transplantation
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Nima Nabavizadeh, MD
role: PRINCIPAL_INVESTIGATOR
References: