Condition: Metastatic Digestive System Neuroendocrine Tumor G1 · Metastatic Digestive System Neuroendocrine Tumor G2 · Unresectable Digestive System Neuroendocrine Tumor G1 · Sponsor: National Cancer Institute (NCI)
This phase II trial compares the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus, sunitinib, or cabozantinib in patients who have previously received 177Lu-DOTATATE for gastroenteropancreatic neuroendocrine tumor (GEPNET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable). PRRT is a type of radiation therapy for which a radioactive chemical is linked to a peptide (small protein) that targets tumor cells. When this radioactive peptide is injected into the body, it binds to a specific receptor found on some tumor cells. The radioactive peptide builds up in these cells and helps kill the tumor cells without harming normal cells. In this trial 177Lu-DOTATATE is used for PRRT. 177Lu-DOTATATE PRRT may increase the length of time until worsening of the GEPNET compared to the usual approach. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping tumor cells from reproducing and by decreasing blood supply to the tumor cells. Sunitinib and cabozantinib, block certain proteins, which may help keep tumor cells from growing. They may also prevent the growth of new blood vessels that tumors need to grow. Sunitinib malate is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Retreating with 177Lu…
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| University of Alabama at Birmingham Cancer Center | Birmingham, Alabama, United States | Suspended |
| Mayo Clinic Hospital in Arizona | Phoenix, Arizona, United States | Recruiting |
| Banner University Medical Center - Tucson | Tucson, Arizona, United States | Suspended |
| University of Arizona Cancer Center-North Campus | Tucson, Arizona, United States | Suspended |
| UCHealth University of Colorado Hospital | Aurora, Colorado, United States | Recruiting |
| UM Sylvester Comprehensive Cancer Center at Aventura | Aventura, Florida, United States | Recruiting |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables, Florida, United States | Recruiting |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach, Florida, United States | Recruiting |
| Mayo Clinic in Florida | Jacksonville, Florida, United States | Recruiting |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida, United States | Recruiting |
| UM Sylvester Comprehensive Cancer Center at Kendall | Miami, Florida, United States | Recruiting |
| University of Miami Sylvester Comprehensive Cancer Center at Sole Mia | North Miami, Florida, United States | Recruiting |
+ 27 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05773274