Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer
NCT ID: NCT03186898
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
186 participants
INTERVENTIONAL
2018-01-26
2027-06-30
Brief Summary
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Detailed Description
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I. To determine if overall survival (OS) is different for hepatocellular carcinoma patients treated with protons compared to photons.
SECONDARY OBJECTIVES:
I. To determine the difference in progression-free-survival (PFS) in patients with hepatocellular carcinoma (HCC) treated with protons compared to patients with HCC treated with photons.
II. To determine the difference in local progression (LP) in patients with HCC treated with protons compared to patients with HCC treated with photons.
III. To determine differences in toxicity in patients with HCC treated with protons versus photons.
IV. To determine differences in fatigue, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue in patients with HCC treated with protons, versus photons; as well as quality-adjusted survival, if the primary endpoint is met.
V. To determine if there are correlations between the baseline values of hepatocyte growth factor (HGF) and outcomes (OS/PFS/fatigue).
EXPLORATORY OBJECTIVES:
I. To determine differences in overall quality of life, measured by Functional Assessment of Cancer Therapy-Hepatobiliary Cancer (FACT-Hep) in patients with HCC treated with protons.
II. Biospecimen collection for future correlative science projects.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo proton therapy over 15-24 days for 5 or 15 fractions.
ARM II: Patients undergo photon therapy over 15-24 days for 5 or 15 fractions.
Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI) and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for up to 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (proton therapy)
Patients undergo proton therapy over 15-24 days for 5 or 15 fractions. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT scan
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo MRI
Quality-of-Life Assessment
Ancillary studies
Radiation Therapy
Undergo proton therapy
Arm II (photon therapy)
Patients undergo photon therapy over 15-24 days for 5 or 15 fractions. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT scan
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo MRI
Quality-of-Life Assessment
Ancillary studies
Radiation Therapy
Undergo photon therapy
Interventions
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Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT scan
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo MRI
Quality-of-Life Assessment
Ancillary studies
Radiation Therapy
Undergo proton therapy
Radiation Therapy
Undergo photon therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Responsible Party
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Principal Investigators
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Theodore S Hong
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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Emory Proton Therapy Center
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Maryland Proton Treatment Center
Baltimore, Maryland, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
New York Proton Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
M D Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Countries
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Facility Contacts
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References
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Duda DG. Targeting Tumor Microenvironment in Liver Cancers: Rationale, Current Progress, and Future Perspective. Keio J Med. 2022;71(3):71. doi: 10.2302/kjm.71-004-ABST.
Other Identifiers
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NCI-2016-02009
Identifier Type: REGISTRY
Identifier Source: secondary_id
NRG-GI003
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-GI003
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-GI003
Identifier Type: -
Identifier Source: org_study_id