RECRUITING

Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase III Randomized Trial of Protons Versus Photons for Hepatocellular Carcinoma

Quick Facts

Study Start:2018-01-26
Study Completion:2029-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03186898

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Appropriate stage for study entry based on the following diagnostic workup:
  3. * 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
  4. * 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
  5. * Patients 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 legion that is ≥ 1 cm and ≤ 15 cm in greatest dimension is allowed.
  6. * Zubrod performance status 0-1 within 30 days prior to registration
  7. * Negative urine or serum pregnancy test for women of childbearing potential within 7 days prior to study entry
  8. * Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3
  9. * Platelets \>= 50,000 cells/mm\^3
  10. * Hemoglobin \>= 9.0 g/dl; (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 9.0 g/dl is acceptable)
  11. * Total bilirubin \< 4 x institutional upper limit of normal (ULN)
  12. * Transaminases (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) \< 6 x institutional ULN
  13. * Albumin \>= 2.5mg/dl
  14. * Creatinine \< 2 mg/dl
  15. * Prior chemotherapy, targeted biological therapy (e.g. sorafenib), surgery, transarterial chemoembolization (TACE), ablation for present disease is acceptable
  16. * Must have Child-Turcotte-Pugh (CTP) A or B7
  17. * The patient or a legally authorized representative must provide study-specific informed consent prior to study registration
  1. * PRIOR TO STEP ONE RANDOMIZATION:
  2. * 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
  3. * Uncontrolled prior invasive malignancy, excluding the current diagnosis
  4. * Systemic chemotherapy for the study cancer \< 2 weeks prior to registration
  5. * 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.
  6. * 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.
  7. * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields (to include Y90)
  8. * Prior liver transplant
  9. * PRIOR TO STEP TWO RANDOMIZATION:
  10. * Unable to obtain confirmation of payment coverage (insurance or other) for either possible treatment

Contacts and Locations

Principal Investigator

Theodore Hong
PRINCIPAL_INVESTIGATOR
NRG Oncology

Study Locations (Sites)

Emory Proton Therapy Center
Atlanta, Georgia, 30308
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
United States
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Commack
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
United States
New York Proton Center
New York, New York, 10035
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
United States
Case Western Reserve University
Cleveland, Ohio, 44106
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
FHCC South Lake Union
Seattle, Washington, 98109
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: NRG Oncology

  • Theodore Hong, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-01-26
Study Completion Date2029-06-30

Study Record Updates

Study Start Date2018-01-26
Study Completion Date2029-06-30

Terms related to this study

Keywords Provided by Researchers

  • hepatocellular carcinoma
  • HCC
  • Proton Therapy
  • Photon Therapy
  • Liver cancer

Additional Relevant MeSH Terms

  • Unrectable or Locally Recurrent Hepatocellular Carcinoma