Your session is about to expire
β Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 months
Awards & highlights
Study Summary
This trial is testing a new regional therapy for patients with unresectable liver cancer that doesn't fit the criteria for other treatments.
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.Check my eligibility
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.See study design
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 βYesβ 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate to SBRT
Secondary outcome measures
Treatment Related Toxicity
Side effects data
From 2022 Phase 2 trial β’ 29 Patients β’ NCT0204544679%
Cough
64%
Nausea
64%
Dyspnea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Lymphocyte count decreased
21%
Chest pain
21%
Death NOS
21%
Anorexia
21%
Anxiety
21%
Fall
14%
Depression
14%
Wheezing
14%
Hypotension
14%
Diarrhea
14%
Dysphagia
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Dehydration
7%
Amnesia
7%
Dysuria
7%
Hearing impaired
7%
Hypertension
7%
Creatinine increased
7%
Dysgeusia
7%
Eye pain
7%
Confusion
7%
Hypernatremia
7%
Productive cough
7%
Dementia
7%
Hemorrhoids
7%
Pneumonitis
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Blurred vision
7%
Rash
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Sinusitis
7%
Alopecia
7%
Esophagitis
7%
Otitis externa
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy
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
~780
Find a Location
Who is running the clinical trial?
Alberta Health servicesLead Sponsor
156 Previous Clinical Trials
647,710 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the researchers enrolling new participants currently?
"Unfortunately, according to the information posted on clinicaltrials.gov this trial has not been accepting candidates since January 18th 2012. Even though recruitment for this specific study is halted, there are still 225 other medical trials actively seeking participants."
Answered by AI
How hazardous is Stereotactic Body Radiation Therapy to the health of those undergoing it?
"With a score of 2, our team at Power has evaluated Stereotactic Body Radiation Therapy's safety as moderate. Phase 2 trials confirm that the therapy is secure but lack evidence to support efficacy."
Answered by AI
Recent research and studies
Share this study with friends
Copy Link
Messenger