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

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Status: Active

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.

Eligibility 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 >= 4 cm and =< 15 cm in greatest dimension is allowed
  • 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 RANDOMIZATION:
  • 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
  • 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
  • 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

Locations & Contacts

Illinois

Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: Active
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org

Maryland

Baltimore
Maryland Proton Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 410-369-5226
Email: info@mdproton.com
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-888-8823

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-726-5130

Missouri

Saint Louis
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu

Ohio

Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 513-558-4553
Email: uchealthnews@uc.edu

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-312-3961

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine if protons improve overall survival (OS) of hepatocellular carcinoma 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).

TERTIARY 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 up every 3 months for 2 years, every 6 months for 3 years, and then yearly for up to 5 years.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
Theodore Sunki Hong

Trial IDs

Primary ID NRG-GI003
Secondary IDs NCI-2016-02009
Clinicaltrials.gov ID NCT03186898