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Compares treatment options for Hepatocellular Carcinoma
Official title Standard Versus Radiobiologically-Guided Dose Selected SBRT in Liver Cancer
ClinicalTrials.gov ID: NCT04745390
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Hepatocellular carcinoma diagnosed with vascular enhancement of the lesion consistent with hepatocellular carcinoma, and with an elevated AFP, in the...
You likely can't join if
- 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...
See the full eligibility criteria
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.