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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

Age > 18

Primary liver lesion or liver metastases measuring ≤ 25 cm

Must not have

Severe cirrhosis or liver failure defined as Child Pugh >B7

Severe, active co-morbidity, defined as limiting the patient's life to less than 6 months

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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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My liver or bile duct cancer is confirmed by lab tests.

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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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I can take care of myself but may not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver condition is not severe (Child Pugh ≤B7).

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My life expectancy is more than 6 months despite my other health issues.

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I've had radiation in the same area where my current cancer is located.

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I am not pregnant, nursing, or able to become pregnant and will use contraception during the study.

Timeline

Screening ~ 3 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival

Treated lesion progression

Secondary study objectives

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: NOS

12%

Late RT Toxicity: Other GI: NOS

12%

Hemoglobin decreased

12%

Alanine aminotransferase increased

Gynaecomastia

Urinary retention

Pain-other

Aspartate aminotransferase increased

Rectal bleeding

Constipation

Leukopenia NOS

Edema NOS

Hematuria present

Renal/GU-Other

Arthralgia

Blood creatinine increased

Dyspnea NOS

Dermatitis exfoliative NOS

Depression NEC

Nausea

Hyperglycemia NOS

Lymphopenia

Myalgia

Peripheral sensory neuropathy

Platelet count decreased

Hyponatremia

Hypocalcemia

Blood albumin decreased

Stomatitis

Weight decreased

Anorexia

Hematologic-Other

Neutropenia

Alopecia

100%

80%

60%

40%

20%

Study treatment Arm

Hormones and RT

Hormones and RT Plus Chemotherapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 14Eligibility criteria met