Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04745390

Standard Versus Radiobiologically-Guided Dose Selected SBRT in Liver Cancer

Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2025-03-11

110

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Radiation is a standard treatment option for patients with liver cancer. Unfortunately, the tumour grows after radiation in many patients and radiation can harm normal tissues. A new treatment using a specialized radiation procedure called Stereotactic body radiotherapy (SBRT) may increase the chance to control liver cancer and reduce the chance of harm to normal tissues. SBRT allows radiation treatments to be focused more precisely, and be delivered more accurately than with older treatments. SBRT has become a routine treatment. Further research has found that specialized computer programs can possibly guide the selection of an appropriate SBRT dose. This is called radiobiological guidance. However, this has not yet been proven to improve outcomes and/or reduce toxicity. Therefore, the purpose of this study is to find out if SBRT at standard dose versus SBRT guided by radiobiological techniques is better for you and your liver cancer.

CONDITIONS

Official Title

Standard Versus Radiobiologically-Guided Dose Selected SBRT in Liver Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with primary hepatobiliary cancer confirmed by pathology, or non-lymphoma liver metastases confirmed by pathology, or radiographic liver lesions consistent with metastases in a patient with known non-lymphoma cancer, or hepatocellular carcinoma diagnosed by vascular enhancement and elevated AFP with cirrhosis or chronic hepatitis
  • 5 or fewer liver lesions measurable on contrast-enhanced liver CT or MRI within 90 days before study start
  • Liver lesion(s) measuring 25 cm or smaller
  • Extrahepatic cancer allowed if liver involvement is life-limiting
  • No contraindications to radiotherapy
  • Medically or surgically unresectable
  • Zubrod Performance Scale score of 0 to 3
  • Age over 18 years
  • Systemic treatments like multikinase inhibitors or immunotherapy allowed with specific timing restrictions
  • Previous liver surgery or ablative therapy allowed
  • Chemotherapy completed at least 2 weeks before radiation and not planned for 1 week after (4 weeks for anthracyclines)
  • Life expectancy greater than 6 months
  • Women of childbearing potential and men must use adequate contraception
Not Eligible

You will not qualify if you...

  • Severe cirrhosis or liver failure (Child Pugh greater than B7)
  • Prior radiotherapy overlapping the study area
  • Severe active co-morbidity limiting life expectancy to less than 6 months
  • Active hepatitis or significant liver failure (treated hepatitis allowed)
  • Pregnant or nursing women, and those not willing or able to use contraception if of childbearing potential or sexually active men

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

London Regional Cancer Program

London, Ontario, Canada, N6A 5W9

Actively Recruiting

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Research Team

M

Morgan Black

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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