Hepatic Arterial Chemoembolization With Cisplatin or Internal Radiation Therapy in Treating Patients With Advanced Liver Cancer That Cannot Be Removed By Surgery
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing. In this
      case, chemotherapy is given through the artery (hepatic artery) that brings blood to the
      tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and
      keeping chemotherapy drugs near the tumor. Internal radiation uses radioactive material
      placed directly into or near a tumor to kill tumor cells. It is not yet known whether hepatic
      arterial chemoembolization with cisplatin is more effective than internal radiation therapy
      in treating liver cancer.

      PURPOSE: This randomized phase III trial is studying hepatic arterial chemoembolization with
      cisplatin to see how well it works compared to internal radiation therapy in treating
      patients with advanced liver cancer that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare time to disease progression in patients with unresectable advanced
           hepatocellular carcinoma treated with cisplatin-based trans-arterial chemoembolization
           vs hepatic intra-arterial yttrium Y 90 glass microspheres (TheraSphere®).

        -  Compare the health-related quality of life of patients treated with these regimens.

        -  Compare the safety of these regimens in these patients.

      Secondary

        -  Compare survival of patients treated with these regimens.

        -  Compare tumor response by CT scan in patients treated with these regimens.

        -  Compare treatment-related costs, in terms of cost of therapy and number of
           hospitalization days, in these patients.

      OUTLINE: This is a randomized study. Patients are stratified according to extent of tumor in
      the liver (< 50% vs ≥ 50%) and presence of portal hypertension (yes vs no). Patients are
      randomized to 1 of 2 treatment arms.

        -  Arm I: Patients undergo trans-arterial chemoembolization comprising intra-arterial (IA)
           infusion of cisplatin over 30-60 minutes followed by embolization of the hepatic artery
           (that brings blood to the tumor) on day 1. Treatment repeats every 8-10 weeks in the
           absence of disease progression or unacceptable toxicity.

        -  Arm II: Patients receive yttrium Y 90 glass microspheres (TheraSphere®) IA on day 1.
           Beginning 60 days after the first TheraSphere® treatment, patients may receive
           additional treatment with TheraSphere® only if follow-up CT scans show progressive
           disease.

      Quality of life is assessed at baseline and then every 3 months thereafter.

      After the completion of study treatment, patients are followed at 30 days and then every 2
      months for 2 years.

      PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): cisplatin; brachytherapy; yttrium Y 90 glass microspheres
Intervention type(s): Drug; Radiation; Radiation
Intervention MeSH terms: Cisplatin
Allocation: Randomized
Primary purpose: Treatment
Keywords: adult primary hepatocellular carcinoma; advanced adult primary liver cancer; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer