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Radiation Therapy
SBRT for Liver Cancer
Phase 2
Waitlist Available
Led By Robert Nordal, M.D.
Research Sponsored by Alberta Health services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For primary hepatoma, no extra-hepatic disease
Histologically conformation of liver malignancy
Must not have
Ascites
Lesions invading major blood vessels in the porta region
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a type of radiation therapy that uses high-energy rays to target and kill cancer cells in the liver. The treatment works by damaging the DNA of cancer cells to kill them or stop their growth. Modern advances have renewed interest in using this therapy for treating liver cancers.
Who is the study for?
This trial is for people with liver tumors who haven't turned yellow from liver issues, have no cancer outside the liver, and are generally able to carry out daily activities (Karnofsky > 70). They must have a confirmed diagnosis of liver malignancy and tumors that can be targeted by SBRT. It's not for those with major blood vessel involvement, poor liver function, fluid in the abdomen, previous radiation to the liver or reasons they can't get radiation therapy.
What is being tested?
The trial tests Stereotactic Body Radiation Therapy (SBRT) on patients with primary hepato-biliary cancers or gastrointestinal cancer that has spread to the liver. Since many patients cannot undergo surgery and don't qualify for other treatments due to tumor size or location, this study explores if SBRT can control local tumor growth or ease symptoms.
What are the potential side effects?
While specific side effects aren't listed here, typical ones from radiation like SBRT may include fatigue, skin reactions at treatment site, nausea and potential damage to nearby organs such as mild-to-moderate liver dysfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer has not spread outside my liver.
Select...
My liver cancer has been confirmed through tissue examination.
Select...
My liver cancer can be treated with targeted radiation.
Select...
I do not have jaundice or liver problems.
Select...
My original cancer site was treated properly.
Select...
I am mostly able to care for myself.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have fluid buildup in my abdomen.
Select...
My cancer is affecting major blood vessels near my liver.
Select...
I cannot receive radiation therapy in my liver due to health risks.
Select...
My liver is not working properly.
Select...
My cancer has spread outside of my liver.
Select...
I have had radiation therapy to my liver.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2022 Phase 2 trial • 29 Patients • NCT0204544687%
Fatigue
53%
Nausea
33%
Cough
27%
Pain
27%
Dyspnea
27%
Depression
27%
Platelet count decreased
27%
Anemia
27%
Fall
27%
Lymphocyte count decreased
20%
Dizziness
20%
Chills
20%
Edema limbs
20%
Chest pain
20%
Neutropenia
20%
Diarrhea
13%
Dysesthesia
13%
Insomnia
13%
Edema
13%
Constipation
13%
Delirium
13%
Skin infection
13%
Vomiting
13%
Tinnitus
13%
Myalgia
13%
Rash
13%
Back pain
13%
Dysgeusia
13%
Weakness (limb)
13%
Weight loss
7%
Hearing loss
7%
Hypokalemia
7%
Hypoxic respiratory failure
7%
Acute kidney injury
7%
Anxiety
7%
Oral lesions
7%
Lymphocytopenia
7%
Neutrophil count decreased
7%
Weakness (facial)
7%
Seizures
7%
Hearing impaired
7%
Hypernatremia
7%
Creatinine increased
7%
Headache
7%
Headaches
7%
Death NOS
7%
Encephalopathy
7%
Gait disturbance
7%
Nasal congestion
7%
Urinary urgency
7%
Fever
7%
Tremor
7%
Amnesia
7%
Photophobia
7%
Pleural effusion
7%
Proteinuria
7%
Urinary frequency
7%
Dysphagia
7%
Low white blood count
7%
Sneezing
7%
Cognitive disturbance
7%
Muscle weakness
7%
Erythema multitforme
7%
Lung infection
7%
Hypertension
7%
Allergy (seasonal)
7%
Bruising
7%
Hypomagnesemia
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Anorexia
7%
Sleep apnea
7%
Hypoxia
7%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Eligible patient will be treated with 48 Gy in 4 fractions encompassing the entire target lesion in 2 weeks with a minimum of 48 hours between each dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Find a Location
Who is running the clinical trial?
Alberta Health servicesLead Sponsor
162 Previous Clinical Trials
651,443 Total Patients Enrolled
Alberta Health ServicesLead Sponsor
36 Previous Clinical Trials
1,731 Total Patients Enrolled
Robert Nordal, M.D.Principal InvestigatorTom Baker Cancer Centre
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver cancer has not spread outside my liver.My liver cancer has been confirmed through tissue examination.My liver cancer can be treated with targeted radiation.I do not have jaundice or liver problems.My original cancer site was treated properly.I am mostly able to care for myself.I have fluid buildup in my abdomen.My cancer is affecting major blood vessels near my liver.I cannot receive radiation therapy in my liver due to health risks.My liver is not working properly.My cancer has spread outside of my liver.I have had radiation therapy to my liver.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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