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Back|NCT03186898Recruiting
Official Title

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

Phase
Phase 3
Sponsor
NRG Oncology
Enrollment
186
Timeline
Jan 2018 → Jun 2027
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Pathologically (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
  • 2Appropriate stage for study entry based on the following diagnostic workup:
  • 3All 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
  • 4Participants 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
  • 5Patient 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
  • 6Age \>= 18
  • 7Zubrod performance status 0-1 within 30 days prior to registration
  • 8Negative urine or serum pregnancy test for women of childbearing potential within 7 days prior to study entry
  • 9Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3
  • 10Platelets \>= 50,000 cells/mm\^3
  • 11Hemoglobin \>= 9.0 g/dl; (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 9.0 g/dl is acceptable)
  • 12Total bilirubin \< 4 x institutional upper limit of normal (ULN)
  • 13Transaminases (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) \< 6 x institutional ULN
  • 14Albumin \>= 2.5 g/dl
  • 15Creatinine \< 2 mg/dl
  • 16Prior chemotherapy, targeted biological therapy (e.g. sorafenib), surgery, transarterial chemoembolization (TACE), ablation for present disease is acceptable
  • 17Must have Child-Turcotte-Pugh (CTP) A or B7
  • 18The patient or a legally authorized representative must provide study-specific informed consent prior to study registration

Exclusion Criteria

  • 1PRIOR TO STEP ONE REGISTRATION:
  • 2Definitive 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
  • 3Uncontrolled prior invasive malignancy, excluding the current diagnosis
  • 4Systemic chemotherapy for the study cancer \< 2 weeks prior to registration
  • 5Pregnancy 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
  • 6HIV 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
  • 7Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields (to include Y90)
  • 8Prior liver transplant
  • 9PRIOR TO STEP TWO RANDOMIZATION:
  • 10Unable to obtain confirmation of payment coverage (insurance or other) for either possible treatment

Locations

27 sites participating in this study

Emory Proton Therapy Center

Atlanta, Georgia 30308

Recruiting

Pretesh R. Patel

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Pretesh R. Patel

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Pretesh R. Patel

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →