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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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%

Fall

27%

Dyspnea

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

27%

Anemia

20%

Chills

20%

Dizziness

20%

Edema limbs

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

13%

Edema

13%

Dysesthesia

13%

Dysgeusia

13%

Insomnia

13%

Constipation

13%

Delirium

13%

Skin infection

13%

Vomiting

13%

Tinnitus

13%

Myalgia

13%

Rash

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Bruising

Hearing loss

Anxiety

Headaches

Oral lesions

Weakness (facial)

Neutrophil count decreased

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Hearing impaired

Hypernatremia

Creatinine increased

Headache

Death NOS

Gait disturbance

Nasal congestion

Fever

Tremor

Urinary urgency

Hypoxic respiratory failure

Amnesia

Photophobia

Pleural effusion

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Muscle weakness

Erythema multitforme

Lung infection

Hypertension

Allergy (seasonal)

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

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

0 / 12Eligibility criteria met