Study Summary
This trial is testing how well stereotactic body radiation therapy works to treat patients with liver cancer.
Eligible Conditions
- Liver Cancer
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Up to time of progression, transplantation, death or 2-years after last SBRT dose, whichever occurs first
At transplantation
Proportion of histopathologic changes in irradiated tumor sites relative to uninvolved liver tissue
Year 2
Change in QoL scores for Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire
Change in quality of life (QoL) score using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 questionnaire
Month 3
Alanine Transaminase
Year 2
Overall survival
Year 1
Proportion of participants who are transplanted or with localized disease control per Milan criteria
Year 2
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
Incidence of extrahepatic progressive disease
Incidence of intrahepatic progressive disease
Proportion of participants that proceed to transplantation
Month 3
Incidence of liver toxicity assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0
Trial Safety
Phase-Based Safety
Side Effects for
Maintenance Chemotherapy
87%Fatigue
53%Nausea
33%Cough
27%Anemia
27%Pain
27%Dyspnea
27%Depression
27%Fall
27%Lymphocyte count decreased
27%Platelet count decreased
20%Diarrhea
20%Chest pain
20%Neutropenia
20%Edema limbs
20%Chills
20%Dizziness
13%Edema
13%Constipation
13%Weakness (limb)
13%Skin infection
13%Vomiting
13%Dysesthesia
13%Dysgeusia
13%Rash
13%Weight loss
13%Delirium
13%Tinnitus
13%Back pain
13%Insomnia
13%Myalgia
7%Headache
7%Erythema multitforme
7%Pleural effusion
7%Oral lesions
7%Muscle weakness
7%Shingles
7%Neutrophil count decreased
7%Hypoxic respiratory failure
7%Gait disturbance
7%Hypoxia
7%Photophobia
7%Urinary frequency
7%Encephalopathy
7%Fever
7%Lung infection
7%Hearing loss
7%Febrile Neutropenia
7%Hypokalemia
7%Low white blood count
7%Sneezing
7%Creatinine increased
7%Weakness (facial)
7%Bruising
7%Anxiety
7%Hypernatremia
7%Tremor
7%Urinary urgency
7%Headaches
7%Proteinuria
7%Acute kidney injury
7%Allergy (seasonal)
7%Amnesia
7%Anorexia
7%Cognitive disturbance
7%Dysphagia
7%Hearing impaired
7%Hypertension
7%Hypomagnesemia
7%Lymphocytopenia
7%Nasal congestion
7%Parathesia (tingling)
7%Seizures
7%Sleep apnea
7%Death NOS
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
Treatment (SBRT)
1 of 1
Experimental Treatment
15 Total Participants · 1 Treatment Group
Primary Treatment: Stereotactic Body Radiation Therapy · No Placebo Group · N/A
Treatment (SBRT)Experimental Group · 3 Interventions: Questionnaire Administration, Stereotactic Body Radiation Therapy, Quality-of-Life Assessment · Intervention Types: Other, Radiation, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2019
Completed Phase 2
~800
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to time of progression, transplantation, death or 2-years after last sbrt dose, whichever occurs first
Who is running the clinical trial?
Oregon Health and Science UniversityOTHER
913 Previous Clinical Trials
6,830,444 Total Patients Enrolled
1 Trials studying Liver Cancer
339 Patients Enrolled for Liver Cancer
OHSU Knight Cancer InstituteLead Sponsor
214 Previous Clinical Trials
2,089,711 Total Patients Enrolled
1 Trials studying Liver Cancer
339 Patients Enrolled for Liver Cancer
Radiation Oncology InstituteUNKNOWN
1 Previous Clinical Trials
Nima Nabavizadeh, MDPrincipal Investigator - OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You can participate if you have had radiation therapy or radioembolization in the past, but not other types of treatment for your previous medical condition.
You are expected to live for at least 12 more weeks.
If you choose abstinence as your preferred method of birth control, it is accepted.
Frequently Asked Questions
Is this investigation enlisting participants presently?
"The official records from clinicaltrials.gov state that this research study is open for participants and has been since February 7th 2019. The trial was most recently amended on September 22nd 2022." - Anonymous Online Contributor
Unverified Answer
How many test subjects are involved in this experiment?
"Affirmative, according to clinicaltrials.gov this research is actively recruiting eligible participants. It was originally posted on February 7th 2019 and the latest update occurred on September 22nd 2022. For now, they are targeting 15 individuals from a single site." - Anonymous Online Contributor
Unverified Answer