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Radiation Therapy

Standard vs Targeted Radiation Therapy for Liver Cancer (SAVIOR Trial)

N/A
Recruiting
Led By Michael Lock, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be judged medically or surgically unresectable
Multikinase inhibitors must be held 2 weeks prior to radiation and may be restarted 1 week post radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of first documented extrahepatic failure or date of death from any cause, whichever came first, assessed up to 2 years
Awards & highlights

SAVIOR Trial Summary

This trial is comparing two different types of radiation therapy for people with liver cancer. Standard radiation therapy is when doctors use lower doses of radiation to try and kill the cancer cells. The second type is called SBRT, which is when doctors use higher doses of radiation and try to target the cancer cells more specifically. The trial is testing to see if SBRT is more effective in treating liver cancer and if it has less side effects than standard radiation therapy.

Who is the study for?
This trial is for adults with liver cancer that can't be removed by surgery. It's open to those with primary liver cancer or certain types of liver metastases, up to 5 measurable lesions, and a life expectancy over 6 months. Patients must not have severe illnesses limiting life span under 6 months, active hepatitis, severe cirrhosis (Child Pugh >B7), or prior overlapping radiation therapy.Check my eligibility
What is being tested?
The study compares standard dose SBRT versus radiobiologically-guided SBRT in treating liver cancer. The goal is to see if the guided approach better controls the cancer while reducing harm to healthy tissues compared to the standard treatment.See study design
What are the potential side effects?
Potential side effects include damage to normal liver tissue leading to decreased liver function, fatigue from radiation treatments, and possible skin changes at the site of radiation.

SAVIOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition cannot be treated with surgery.
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I stopped taking multikinase inhibitors 2 weeks before radiation and can restart 1 week after.
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I am older than 18 years.
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My liver cancer or liver metastases is 25 cm or smaller.
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I have received treatments like immunotherapy or drugs targeting multiple kinases.
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My liver or bile duct cancer is confirmed by lab tests.
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I have had surgery or treatment to remove or destroy liver tissue.
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My liver cancer spread is confirmed and not lymphoma.
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I have cancer that has spread to my liver, confirmed by scans.
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I can safely undergo radiotherapy.
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I have liver cancer with specific blood test results and liver condition.
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I have 5 or fewer liver tumors visible on a recent scan.
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I finished chemotherapy at least 2 weeks ago and won't start again for at least 1 week after radiation.
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My liver cancer is considered life-limiting despite having cancer elsewhere.
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I can take care of myself but may not be able to do heavy physical work.

SAVIOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of first documented extrahepatic failure or date of death from any cause, whichever came first, assessed up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of first documented extrahepatic failure or date of death from any cause, whichever came first, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival
Treated lesion progression
Secondary outcome measures
Comparison of Quality of Life (QOL) Using a Standardly-Used Validated Instrument. Specifically, measures of physical, social/family, and functional well being. Overall symptoms, function, global health status will also be compared.
Extrahepatic failure
Response rate - Modified RECIST criteria
+2 more

Side effects data

From 2013 Phase 3 trial • 397 Patients • NCT00004054
78%
Menopausal symptoms
60%
Urinary frequency
52%
Impotence
47%
Late RT Toxicity: Bladder: NOS
39%
Diarrhea NOS
27%
Late RT Toxicity: Bowel: NOS
26%
Fatigue
26%
Late RT Toxicity: Other GU: NOS
21%
Proctitis NOS
21%
Dysuria
14%
Libido decreased
14%
Dermatitis radiation NOS
12%
Late RT Toxicity: Other GI: NOS
12%
Late RT Toxicity: Other: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Nausea
2%
Hyperglycemia NOS
2%
Depression NEC
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Stomatitis
1%
Blood albumin decreased
1%
Platelet count decreased
1%
Weight decreased
1%
Anorexia
1%
Hypocalcemia
1%
Hyponatremia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy

SAVIOR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized Dose Selection RadiationExperimental Treatment1 Intervention
Patients in the experimental arm will receive individually selected prescription dose guided by radiobiological parameters described below, preferably delivered in 5 fractions every other day, excluding weekends and holidays. Volumetric-modulated arc therapy (VMAT) is the preferred planning technique. Typical planning uses 2 arcs, <=10MV and FFF mode where possible as almost all liver treatments are gated). In the event of multiple lesions, multiple isocentres are allowed. Often lateral isocentre shifts are significant and therefore arc ranges should be chosen to minimize collision risk. Treatment will be every second day excluding weekends and holidays.
Group II: Standard Dose RadiationActive Control1 Intervention
Patients in the standard arm will receive a standard dose of 2000cGy in 5 fractions using simple CT planning. IMRT is allowed. Treatment will be every second day excluding weekends and holidays.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation therapy
2013
Completed Phase 3
~2850

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
655 Previous Clinical Trials
413,229 Total Patients Enrolled
Michael Lock, MDPrincipal InvestigatorLawson Health Research Institute
2 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Radiation therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04745390 — N/A
Liver Cancer Research Study Groups: Personalized Dose Selection Radiation, Standard Dose Radiation
Liver Cancer Clinical Trial 2023: Radiation therapy Highlights & Side Effects. Trial Name: NCT04745390 — N/A
Radiation therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04745390 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals have been set for this medical investigation?

"This medical study will observe the overall survival of participants over a 6-month period. Secondary outcomes to be measured include Quality of Life (QOL) using a validated instrument, comprising physical, social/family, and functional well being metrics; FACT-Hepatobiliary questionnaire scores which range from 0 - 180 points with lower scores indicating better health; NCI-CTCAE 5.0 Score System toxicity grades ranging between 1-5; and extrahepatic failure determined by any new lesions outside of the liver organ."

Answered by AI

Is it possible to sign up as a participant in this clinical trial at the present moment?

"The available data on clinicaltrials.gov confirms that this trial is presently recruiting patients, having been posted initially on August 1st 2021 and last updated November 8th 2022."

Answered by AI

How many individuals are currently receiving treatment from this clinical experiment?

"Affirmative. Per the information on clinicaltrials.gov, this medical trial is still recruiting patients since it was first published in August of 2021 and last updated November 8th 2022. 110 participants are intended to be recruited from a single site."

Answered by AI
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~47 spots leftby Apr 2026