TheraSphere for the Treatment of Liver Metastases
Condition: Colorectal Cancer; Carcinoma, Neuroendocrine; Neoplasm Metastasis
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis; Carcinoma, Neuroendocrine
Intervention: Yttrium 90 glass microspheres
Intervention description: 120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TheraSphere; radioactive microspheres; Yttrium-90; Yttrium glass microspheres

Summary:

      This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere
      treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with
      metastatic disease to the liver that cannot be treated or is progressing following treatment
      with systemic or other liver-directed therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  diagnosis of metastatic disease to the liver that is refractory to, or inappropriate
             for, other systemic or liver-directed therapies

          -  unresectable liver metastases

          -  target tumors measurable using standard imaging techniques

          -  tumor replacement < or = 50% of total liver volume (visual estimation by investigator)

          -  Hypervascular tumors (visual estimation by investigator)

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

          -  minimum one month since most recent prior cancer therapy with the exception of
             patients receiving Sandostatin for neuroendocrine cancer

          -  patient informed consent

        Exclusion Criteria:

          -  At risk of hepatic or renal failure within 21 days of treatment (serum creatinine >
             2.0 mg/dL unless on dialysis; serum bilirubin ≥ 2.0 mg/dL; albumin < 2.0 mg/dL or any
             history of hepatic encephalopathy)

          -  contraindications to angiography and selective visceral catheterization including any
             non-correctable bleeding diathesis or coagulopathy, severe peripheral vascular disease
             or history of non-management allergy or intolerance to contrast, narcotics, sedatives
             or atropine

          -  severe liver dysfunction or presentation of pulmonary insufficiency or clinically
             evident history of chronic obstructive pulmonary disease

          -  cirrhosis or portal hypertension

          -  prior external beam radiation treatment to the liver

          -  prior TheraSphere treatment to the liver

          -  any intervention for, or compromise of the Ampulla of Vater

          -  clinically evident ascites (trace ascites on imaging is acceptable)

          -  any continuing complications of prior cancer therapy that have not improved or
             resolved prior to 21 days before first TheraSphere treatment

          -  significant life-threatening extrahepatic disease in judgment of physician

          -  concurrent enrollment in another study

          -  alternative available therapies in judgement of physician

          -  evidence on technetium-99m macroaggregated albumin scan that shows lung shunting > 30
             Gy cumulative limit

          -  evidence on technetium-99m macroaggregated albumin scan showing potential for
             deposition of microspheres to the gastrointestinal tract that cannot be eliminated by
             catheter placement or corrective action using standard angiographic techniques

          -  positive serum pregnancy test in women of childbearing potential

          -  co-morbid disease or condition that puts the patient at undue risk or precludes use of
             TheraSphere in judgment of physician