Standard Versus Radiobiologically-Guided Dose Selected SBRT in Liver Cancer

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Feb 8, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to use a specialized radiation treatment called Stereotactic Body Radiotherapy (SBRT) for patients with liver cancer, specifically hepatocellular carcinoma or liver metastases. The study aims to compare the standard SBRT dose with a new method that uses computer programs to help select the best dose for each patient. The hope is that this guided approach will lead to better control of the cancer while minimizing damage to healthy tissues.

To participate in the trial, patients must be at least 18 years old and have certain types of liver cancer that can be measured through imaging tests like CT or MRI. Participants should have no more than five measurable liver lesions, and their cancer should not be easily treatable with surgery. They also need to be well enough overall to handle the treatment. During the trial, patients can expect to receive either the standard SBRT or the radiobiologically-guided SBRT, and they will be closely monitored to see which method works better. It's important to know that the trial is currently recruiting, so there are opportunities for eligible patients to join and contribute to this research.

Gender

ALL

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.