TriangleThe film gives the main points. The full list below is copied from the registry; the study team makes the final decision.
- Age18 Years to no maximum
- SexAll
- Healthy volunteersNo
You may be able to join if
- Patients with confirmed diagnosis of histologic grade 2 or 3 well differentiated neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present)
- Patients with at least one measurable liver metastases, with size > 1cm (RECIST criteria)
- Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver
- Liver tumor burden does not exceed 50% of the liver volume
- Patent main portal vein
- At least 4 weeks since last administration of last chemotherapy and /or radiotherapy
- Age >18 years.
- Life expectancy of greater than 6 months.
- ECOG performance status 0-2.
- Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl.
- Patients must have adequate organ and marrow function as defined below:
- platelets >100,000/mcL (may be corrected by transfusion)
- serum creatinine < 2.0 mg/dl
- INR <1.6, (may be corrected by transfusion)
- Ability to understand and the willingness to sign a written informed consent document.
- Women of child bearing potential and fertile men are required to use effective contraception (negative urine or serum βHCG for women of child-bearing age)
You cannot join if
- Contraindications to capecitibine or temozolomide
- Contraindicated for both contrast-enhanced MRI and CT
- Patients previously treated with transarterial embolization (with or without chemotherapy) or with radioembolization (Y-90 microspheres)
- Contraindication for radioembolization procedures:
- excessive hepatopulmonary shunt as determined by the investigator
- inability to deliver Y90 microspheres without risk of non-target embolization of extra-hepatic structures
- Subjects consenting to the trial who fail their simulation angiography will be removed from the study and replaced.
- Patients may not be receiving any other investigational agents.
- Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).
- Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla;
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and lactating women are ineligible