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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 below
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My liver cancer has not spread outside my liver.
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My liver cancer has been confirmed through tissue examination.
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My liver cancer can be treated with targeted radiation.
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I do not have jaundice or liver problems.
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My original cancer site was treated properly.
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I am mostly able to care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have fluid buildup in my abdomen.
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My cancer is affecting major blood vessels near my liver.
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I cannot receive radiation therapy in my liver due to health risks.
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My liver is not working properly.
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My cancer has spread outside of my liver.
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I have had radiation therapy to my liver.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
87%
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

Stereotactic Body Radiation Therapy (SBRT) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00691691 — Phase 2
Liver Cancer Research Study Groups: 1
Liver Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy (SBRT) Highlights & Side Effects. Trial Name: NCT00691691 — Phase 2
Stereotactic Body Radiation Therapy (SBRT) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00691691 — Phase 2
~4 spots leftby Oct 2025