Comparing proton and photon radiation therapy for liver cancer treatment
Official title: A Phase III Randomized Trial of Protons Versus Photons for Hepatocellular Carcinoma
Run by NRG Oncology · NCT03186898 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether proton therapy works better than photon therapy for treating liver cancer by looking at how long patients live and how well they feel during treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 186 (estimated) |
| Sponsor | NRG Oncology Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 26 sites (Atlanta, Georgia and 25 other locations) |
| Trial ID | NCT03186898 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with unresectable or locally recurrent hepatocellular carcinoma who have measurable disease.
✕Probably not a fit
Patients with resectable liver cancer or those with extensive disease beyond the eligibility criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase III trial investigates the effectiveness of proton therapy versus photon therapy in treating patients with liver cancer, specifically focusing on overall survival and progression-free survival rates. Patients will be randomly assigned to receive either proton therapy or photon therapy over a period of 15-24 days. The study also aims to assess differences in local progression, toxicity, fatigue, and quality of life between the two treatment groups. Additionally, biospecimens will be collected for future research.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients with liver cancer.
How similar studies have gone: Other studies have shown promising results with proton therapy in various cancers, suggesting potential benefits in this novel application for liver cancer.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Emory Proton Therapy Center
Atlanta, Georgia, United States Recruiting -
Emory University Hospital Midtown
Atlanta, Georgia, United States Recruiting -
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States Recruiting -
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States Recruiting -
Maryland Proton Treatment Center
Baltimore, Maryland, United States Recruiting -
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States Recruiting
Show 20 more locations
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States Recruiting -
Corewell Health Dearborn Hospital
Dearborn, Michigan, United States Recruiting -
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States Recruiting -
Corewell Health Beaumont Troy Hospital
Troy, Michigan, United States Recruiting -
Washington University School of Medicine
Saint Louis, Missouri, United States Recruiting -
New York Proton Center
New York, New York, United States Recruiting -
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States Recruiting -
Case Western Reserve University
Cleveland, Ohio, United States Recruiting -
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States Recruiting -
M D Anderson Cancer Center
Houston, Texas, United States Recruiting -
Fred Hutchinson Cancer Center
Seattle, Washington, United States Recruiting -
University of Washington Medical Center - Montlake
Seattle, Washington, United States Recruiting -
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States Active not recruiting -
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States Active not recruiting -
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States Active not recruiting -
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States Active not recruiting -
Memorial Sloan Kettering Commack
Commack, New York, United States Active not recruiting -
Memorial Sloan Kettering Westchester
Harrison, New York, United States Active not recruiting -
Memorial Sloan Kettering Cancer Center
New York, New York, United States Active not recruiting -
Memorial Sloan Kettering Nassau
Uniondale, New York, United States Active not recruiting
Study contacts
- Principal investigator: Theodore S Hong — NRG Oncology
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Combined immunotherapy and stereotactic radiotherapy to shrink unresectable liver cancer for possible surgery
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.