CapTemY90 for Grade 2 NET Liver Metastases
- Conditions
- Neuroendocrine Tumor Grade 2Neuroendocrine Tumors
- Registration Number
- NCT04339036
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria:<br><br> - Patients with confirmed diagnosis of histologic grade 2 neuroendocrine tumor with<br> unresectable liver metastases (primary tumor or other extrahepatic disease may be<br> present)<br><br> - Patients with at least one measurable liver metastases, with size > 1cm (RECIST<br> criteria)<br><br> - Patients with liver dominant disease defined as =50% tumor body burden confined to<br> the liver<br><br> - Liver tumor burden does not exceed 50% of the liver volume<br><br> - Patent main portal vein<br><br> - At least 4 weeks since last administration of last chemotherapy and /or radiotherapy<br><br> - Age >18 years.<br><br> - Life expectancy of greater than 6 months.<br><br> - ECOG performance status 0-2.<br><br> - Adequate liver function as measured by: Total bilirubin = 2.0mg/dl, ALT, AST =5<br> times ULN, albumin =2.5g/dl.<br><br> - Patients must have adequate organ and marrow function as defined below:<br><br> - platelets >100,000/mcL (may be corrected by transfusion)<br><br> - serum creatinine < 2.0 mg/dl<br><br> - INR <1.6, (may be corrected by transfusion)<br><br> - Ability to understand and the willingness to sign a written informed consent<br> document.<br><br> - Women of child bearing potential and fertile men are required to use effective<br> contraception (negative urine or serum ßHCG for women of child-bearing age)<br><br>Exclusion Criteria:<br><br> - Contraindications to capecitibine or temozolomide<br><br> - Contraindicated for both contrast-enhanced MRI and CT<br><br> - Patients previously treated with transarterial embolization (with or without<br> chemotherapy) or with radioembolization (Y-90 microspheres)<br><br> - Contraindication for radioembolization procedures:<br><br> - excessive hepatopulmonary shunt as determined by the investigator<br><br> - inability to deliver Y90 microspheres without risk of non-target embolization of<br> extra-hepatic structures<br><br> - Subjects consenting to the trial who fail their simulation angiography will be<br> removed from the study and replaced.<br><br> - Patients may not be receiving any other investigational agents.<br><br> - Absolute contraindication to intravenous iodinated contrast (Hx of significant<br> previous contrast reaction, not mitigated by appropriate pre-medication).<br><br> - Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal<br> papilla;<br><br> - Uncontrolled intercurrent illness including, but not limited to, ongoing or active<br> infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac<br> arrhythmia, or psychiatric illness/social situations that would limit compliance<br> with study requirements.<br><br> - Pregnant and lactating women are ineligible
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intra-hepatic progression-free survival
- Secondary Outcome Measures
Name Time Method Overall Progression free survival;Intra-hepatic tumor responses by RECIST;Intra-hepatic tumor responses by EASL;extra-hepatic tumor responses;Number of participants with systemic toxicities;Number of participants with hepatic toxicities;Change in CgA over time;Quality of Life by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Neuroendocrine tumor