Status:
RECRUITING
Standard Versus Radiobiologically-Guided Dose Selected SBRT in Liver Cancer
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Hepatocellular Carcinoma
Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Primary and secondary (aka liver metastases) hepatobiliary cancer cause substantial morbidity in an increasing number of patients primarily due to the fact that only a minority of patients are suitabl...
Eligibility Criteria
Inclusion
- 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.
- ≤ 5 liver lesions measurable on a contrast-enhanced liver CT or MRI performed within 90 days prior to study entry.
- Primary liver lesion or liver metastases measuring ≤ 25 cm.
- Extrahepatic cancer is permitted if liver involvement is judged to be life-limiting
- No contraindications to radiotherapy
- Patient must be judged medically or surgically unresectable
- Zubrod Performance Scale = 0-3
- Age \> 18
- 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.
- Previous liver resection or ablative therapy is permitted
- 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.
- Life expectancy \> 6 months.
- Women of childbearing potential and male participants must practice adequate contraception.
Exclusion
- Severe cirrhosis or liver failure defined as Child Pugh \>B7
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Severe, active co-morbidity, defined as limiting the patient's life to less than 6 months
- Active hepatitis or clinically significant liver failure. Treated hepatitis is permitted.
- 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.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04745390
Start Date
August 1 2021
End Date
April 1 2027
Last Update
March 11 2025
Active Locations (1)
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1
London Regional Cancer Program
London, Ontario, Canada, N6A 5W9