NCT04745390Recruiting
Standard Versus Radiobiologically-Guided Dose Selected SBRT in 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).
Source: ClinicalTrials.gov · Last updated 11 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 23 Jan 2021
- Start date
- 1 Aug 2021
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04745390
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 1 Aug 2021 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Other illness
- Severe cirrhosis or liver failure defined as Child Pugh \>B7
- Active hepatitis or clinically significant liver failure. Treated hepatitis is permitted.
Other
- Severe, active co-morbidity, defined as limiting the patient's life to less than 6 months
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Regional Cancer Program Coordinator of this site? Confirm its status | London | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.