PHASE II RANDOMIZED, PROSPECTIVE TRIAL OF LUTETIUM LU 177 DOTATATE PRRT VERSUS CAPECITABINE AND TEMOZOLOMIDE IN WELL-DIFFERENTIATED PANCREATIC NEUROENDOCRINE TUMORS: THE COMPARENET TRIAL
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Tenner, Laura
Contact Information:
Jessica Delaney
jessdelaney@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05247905?term=NCT05247905&rank=1
Summary
Primary Objective
To determine the differences in median progression-free survival (PFS) for lutetium Lu 177 dotatate PRRT when compared to capecitabine and temozolomide (CAPTEM) in patients with locally advanced or metastatic progressive, well-differentiated pancreatic neuroendocrine tumors (pNETs).
Secondary Objectives
2.2.1 To evaluate and compare the overall survival (OS) of patients receiving lutetium Lu 177 dotatate vs. CAPTEM
2.2.2 To evaluate and compare time to response, time to maximum response, and overall response rates (ORR) by RECIST version 1.1 between both arms
2.2.3 To evaluate and compare duration of response and time to progression among both arms
2.2.4 To evaluate and compare treatment related toxicities between the arms
2.2.5 To compare global health status/quality of life as measured with the EORTC QLQ-C30 from baseline through 18 months between patients with pNET treated with lutetium Lu 177 dotatate PRRT versus capecitabine and temozolomide.
Exploratory Objectives
2.3.1 To evaluate and compare the correlation to median PFS and response rate (RR) according to local pathology KI67% reported in archival tissue
2.3.2 To evaluate and compare SUV uptake on pre-treatment 68Ga-DOTATATE PET-CT or DOTATOC imaging in correlation to PFS and RR
2.3.3 To evaluate the effect of pre-treatment hepatic disease burden on PFS
2.3.5 To describe post-protocol therapies and late hematologic AEs in this patient population. In particular, to explore and characterize late toxicities of lutetium Lu 177 dotatate therapy, with focus on the incidence rates of renal dysfunction, myelodysplastic syndrome, and acute leukemia.
2.3.6 To compare physical functioning, fatigue, nausea/vomiting, and diarrhea as measured with the EORTC QLQ-C30 from baseline through 18 months between patients with pNET treated with lutetium Lu 177 dotatate PRRT versus capecitabine and temozolomide.
2.3.7 To compare global health status/quality of life, physical functioning, fatigue, nausea/vomiting, and diarrhea as measured with the EORTC QLQ-C30 from baseline through 6 months between patients with pNET treated with lutetium Lu 177 dotatate PRRT versus capecitabine and temozolomide.
2.3.8 To compare all other EORTC QLQ-C30 scales (i.e., role functioning, emotional functioning, cognitive functioning, social functioning, pain, dyspnea, insomnia, appetite loss, constipation, financial difficulties) from baseline through 18 months between patients with pNET treated with lutetium Lu 177 dotatate PRRT versus capecitabine and
temozolomide.
2.3.9 To compare all other EORTC QLQ-C30 scales (i.e., role functioning, emotional functioning, cognitive functioning, social functioning, pain, dyspnea, insomnia, appetite loss, constipation, financial difficulties) from baseline through 6 months between patients with pNET treated with lutetium Lu 177 dotatate PRRT versus capecitabine and temozolomide.