Proton beams vs X-Rays: which is better for liver cancer?
NCT ID NCT03186898
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This phase III trial tests whether proton radiation therapy works better than standard photon (X-ray) radiation for people with liver cancer that cannot be removed by surgery or has come back. The study involves 115 participants and compares overall survival and side effects. Proton therapy may stop more precisely at the tumor, possibly sparing healthy tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton radiation therapy
- What this could lead to
- If successful, this could establish proton therapy as a better standard treatment for liver cancer, potentially improving survival and reducing damage to healthy organs.
- What could go wrong
- This is a mid-stage trial with only 115 participants, so results may not apply to all liver cancer patients. The study is not yet complete, and the expected benefit may not be confirmed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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115 people
The number who actually took part.
- Started
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Jan 2018
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pathologically (histologically or cytologically) or radiographically-proven (based on the American Association for the Study of Liver Diseases \[AALSD\] criteria) unresectable or locally recurrent hepatocellular cancer prior to registration * Appropriate stage for study entry based on the following diagnostic workup: * All patients must have computed tomography (CT) scan chest/abdomen/pelvis with multiphasic liver CT scan prior to registration; if CT contrast is contraindicated, CT chest without contrast and magnetic resonance imaging (MRI) of abdomen is permitted * Participants must have measurable disease at study entry, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 2 cm with conventional techniques or as \> 1 cm with spiral CT scan * Patient must have 3 or fewer single or multinodular tumors; for patients with a single lesion, lesion must be 15 cm or less in greatest dimension; for patients with two lesions, no lesion may be greater than 10 cm in greatest dimension; for patients with three lesions, no lesion may be greater than 6 cm in greatest dimension; portal vein involvement or thrombosis combined with a single lesion that is \>= 1 cm and =\< 15 cm in greatest dimension is allowed * Age \>= 18 * Zubrod performance status 0-1 within 30 days prior to registration * Negative urine or serum pregnancy test for women of childbearing potential within 7 days prior to study entry * Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3 * Platelets \>= 50,000 cells/mm\^3 * Hemoglobin \>= 9.0 g/dl; (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 9.0 g/dl is acceptable) * Total bilirubin \< 4 x institutional upper limit of normal (ULN) * Transaminases (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) \< 6 x institutional ULN * Albumin \>= 2.5 g/dl * Creatinine \< 2 mg/dl * Prior chemotherapy, targeted biological therapy (e.g. sorafenib), surgery, transarterial chemoembolization (TACE), ablation for present disease is acceptable * Must have Child-Turcotte-Pugh (CTP) A or B7 * The patient or a legally authorized representative must provide study-specific informed consent prior to study registration Exclusion Criteria: * PRIOR TO STEP ONE REGISTRATION: * Definitive clinical or radiologic documentation of extrahepatic tumor, defined as extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) \> 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions); note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is \> 2.0 cm * Uncontrolled prior invasive malignancy, excluding the current diagnosis * Systemic chemotherapy for the study cancer \< 2 weeks prior to registration * Pregnancy 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 significantly teratogenic * HIV positive with CD4 count \< 200 cells/microliter; note that patients who are human immunodeficiency virus (HIV) positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count \>= 200 cells/microliter prior to registration; note also that HIV testing is not required for eligibility for this protocol; this exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields (to include Y90) * Prior liver transplant * PRIOR TO STEP TWO RANDOMIZATION: * Unable to obtain confirmation of payment coverage (insurance or other) for either possible treatment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Case Western Reserve University
Cleveland, Ohio, 44106, United States
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Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085, United States
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Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
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Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
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Emory Proton Therapy Center
Atlanta, Georgia, 30308, United States
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Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
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Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
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Maryland Proton Treatment Center
Baltimore, Maryland, 21201, United States
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
East White Plains, New York, 10604, United States
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New York Proton Center
New York, New York, 10035, United States
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Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
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University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
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University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
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University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
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University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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- Can a Three-Pronged attack shrink untreatable liver tumors?
- Can an IDO1 inhibitor boost immunotherapy against liver cancer?
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- Immunotherapy combo tested against untreatable liver cancer
- Liver cancer drug combo shows promise in large trial