Comparing standard and guided radiation therapy for liver cancer

A Phase III Randomized Trial of Standard Dose Stereotactic Body Radiation Therapy (SBRT) Versus Radiobiologically-Guided Dose Selected SBRT In Primary or Secondary Liver Carcinoma (SAVIOR).

This study is testing if a new way of guiding radiation therapy can help people with liver cancer get better results and less damage to healthy tissue compared to the standard method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Academic / other)
• Drugs / interventions: Chemotherapy, immunotherapy, radiation
• Locations: 1 site (London, Ontario)
• Trial ID: NCT04745390 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of standard Stereotactic Body Radiation Therapy (SBRT) versus SBRT guided by radiobiological techniques in treating liver cancer. The aim is to determine if the guided approach can improve cancer control and reduce damage to healthy tissues compared to the standard method. Patients with primary hepatobiliary cancer or liver metastases will be enrolled, and their treatment outcomes will be monitored. The study seeks to provide insights into optimizing radiation therapy for better patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include patients with unresectable primary hepatobiliary cancer or liver metastases who meet specific eligibility criteria.

Not a fit: Patients with resectable liver cancer or those with contraindications to radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with liver cancer, potentially enhancing survival rates and reducing side effects.

How similar studies have performed: While SBRT has become a routine treatment, the specific approach of using radiobiological guidance is still being evaluated and has not been widely tested.

Eligibility criteria

Inclusion Criteria:

1. Eligible patients include patients with any of the following:

   * Primary hepatobiliary cancer confirmed pathologically or,
   * Non-lymphoma liver metastases confirmed pathologically or,
   * Radiographic liver lesions most consistent with metastases, in a patient with known pathologically proven non-lymphoma cancer and a previously negative CT or MRI of the liver or,
   * Hepatocellular carcinoma diagnosed with vascular enhancement of the lesion consistent with hepatocellular carcinoma, and with an elevated AFP, in the setting of cirrhosis or chronic hepatitis.
2. ≤ 5 liver lesions measurable on a contrast-enhanced liver CT or MRI performed within 90 days prior to study entry.
3. Primary liver lesion or liver metastases measuring ≤ 25 cm.
4. Extrahepatic cancer is permitted if liver involvement is judged to be life-limiting
5. No contraindications to radiotherapy
6. Patient must be judged medically or surgically unresectable
7. Zubrod Performance Scale = 0-3
8. Age \> 18
9. Systemic treatment including multikinase inhibitors and immunotherapy are allowed.

   Multikinase inhibitors must be held 2 weeks prior to radiation and may be restarted 1 week post radiation.
10. Previous liver resection or ablative therapy is permitted
11. Chemotherapy must be completed at least 2 weeks prior to radiation therapy and not planned to be administered for at least 1 week (for anthracyclines at least 4 weeks) after completion of treatment.
12. Life expectancy \> 6 months.
13. Women of childbearing potential and male participants must practice adequate contraception.

Exclusion Criteria:

1. Severe cirrhosis or liver failure defined as Child Pugh \>B7
2. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
3. Severe, active co-morbidity, defined as limiting the patient's life to less than 6 months
4. Active hepatitis or clinically significant liver failure. Treated hepatitis is permitted.
5. Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be teratogenic.

Where this trial is running

London, Ontario

• London Regional Cancer Program — London, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Michael Lock, MD — London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
• Study coordinator: Morgan Black

Conditions Hepatocellular Carcinoma; Liver Metastases; Radiation Therapy; Stereotactic Body Radiation Therapy