Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function

This is an interventional treatment trial for Cholangiocarcinoma Read More

Inclusion Criteria:

• Diagnosis of hepatocellular carcinoma, cholangiocarcinoma, or liver metastasis from any histology
• Patients may have single or multinodular tumors
• There is no specific tumor size cut-off for this protocol; however, the radiation treatment plan must meet the protocol's dose constraints

• Compromised liver function as defined by any of the following:

  • Cohort 1: Advanced cirrhosis group

    • Borderline Child-Pugh class A6

    • Child-Pugh class B

      • The patients in this advanced cirrhosis group must have at least 400 ml of functional liver, as estimated on either diagnostic imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) or single photon emission computed tomography (SPECT)/CT with Tc-99m sulfur colloid; there is no upper limit on the functional liver volume for these patients

  • Cohort 2: Low functional liver volume without underlying chronic liver disease

    • Previous irinotecan or oxaliplatin chemotherapy

    • Previous liver resection(s)

      • These patients must have at least 400 ml of functional liver, as estimated by either diagnostic imaging computed tomography or magnetic resonance imaging (CT or MRI) or SPECT/CT with Tc-99m sulfur colloid; there is no upper limit on the functional liver volume for these patients;

  • Cohort 3: History of prior liver-directed radiation therapy with either fractionated external beam radiation therapy (EBRT), stereotactic body radiation therapy (SBRT) or yttrium-90 radioembolization (Y90 RE); the interval between prior EBRT and re-irradiation on protocol should be equal to or greater than 12 months; the interval between prior Y90 RE and re-irradiation on protocol should be equal to or greater than 6 months;

    • Cirrhosis group:

      • Child-Pugh class A5;
      • Borderline Child-Pugh class A6;
      • The patients in this group must have at least 400 ml of functional liver, as estimated on either diagnostic imaging (CT or MRI) or SPECT/CT with Tc-99m sulfur colloid; there is no upper limit on the functional liver volume for these patients

  • Low functional liver volume without underlying liver disease

    • Previous irinotecan or oxaliplatin chemotherapy
    • Previous liver resection(s)
    • These patients must have at least 400 ml of functional liver, as estimated by either diagnostic imaging (CT or MRI) or SPECT/CT with Tc-99m sulfur colloid; there is no upper limit on the functional liver volume for these patients
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• Women of childbearing potential (those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding
• Prior history of surgical resection, chemotherapy, transarterial chemoembolization (TACE), and/or radiofrequency ablation are allowed
• Expected survival must be greater than 3 months
• Patients may receive concurrent capecitabine or sorafenib at the discretion of the treating physicians
• Signed study-specific consent form

Exclusion Criteria:

• Prior liver-directed radiation therapy in cohort 1 (advanced cirrhosis group) or cohort 2 (low functional volume group)
• Prior yttrium-90 therapy for patients in cohorts 1 or 2
• Patients with a Child-Pugh score less than 6 or greater than 9 for radiation naive patients with cirrhosis (cohort 1)
• Child-Pugh score of greater than 6 for patients with cirrhosis who previously received liver directed radiation (EBRT or Y90 RE) (cohort 3)
• Unstable angina and/or symptomatic congestive heart failure requiring hospitalization within the last 6 months; transmural myocardial infarction within the last 6 months prior to study entry
• Current evidence of fever or untreated infection
• Active hepatitis, including but not limited to viral and drug-induced
• Poorly controlled inflammatory bowel disease
• Women with a positive pregnancy test
• Inability to comply with study and/or follow-up procedures
• Patients with an active second malignancy or prior invasive malignancy unless disease free for a minimum of 3 years; non-melanoma skin cancer and previous early prostate cancer that had a non-rising prostate-specific antigen (PSA) can be enrolled