Spots Global Cancer Trial Database for Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer
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Trial Identification
Brief Title: Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer
Official Title: A Phase III Randomized Trial of Protons Versus Photons for Hepatocellular Carcinoma
Study ID: NCT03186898
Study Description
Brief Summary: This phase III trial studies how well radiation therapy with protons works compared with photons in treating patients with liver cancer. Radiation therapy, such as photon therapy, uses high energy x-rays to send the radiation inside the body to the tumor while proton therapy uses a beam of proton particles. Proton therapy can stop shortly after penetrating through the tumor and may cause less damage to the surrounding healthy organs and result in better survival in patients with liver cancer.
Detailed Description: PRIMARY OBJECTIVES: 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 HGF and outcomes (OS/PFS/fatigue). EXPLORATORY OBJECTIVES: I. To determine differences in overall Quality of Life, measured by 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. After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Beaumont Hospital - Dearborn, Dearborn, Michigan, United States
William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States
William Beaumont Hospital - Troy, Troy, Michigan, United States
Washington University School of Medicine, Saint 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
University of Cincinnati Cancer Center-West Chester, West Chester, Ohio, United States
M D Anderson Cancer Center, Houston, Texas, United States
FHCC South Lake Union, Seattle, Washington, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
Contact Details
Name: Theodore Hong
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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