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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
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 β€œYes” 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 months for reporting.

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€’ NCT02045446
79%
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

Stereotactic Body Radiation Therapy (SBRT) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00691691 β€” Phase 2
Liver Cancer Research Study Groups: 1
Liver Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy (SBRT) Highlights & Side Effects. Trial Name: NCT00691691 β€” Phase 2
Stereotactic Body Radiation Therapy (SBRT) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00691691 β€” Phase 2

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
~4 spots leftby Mar 2025