Neoadjuvant PRRT With 177Lu-DOTATATE Followed by Surgery for Resectable PanNET
Status:
Recruiting
Trial end date:
2022-11-30
Target enrollment:
Participant gender:
Summary
Peptide Receptor Radionuclide Therapy (PRRT) is based on specific somatostatin receptor
targeting with radiolabelled analogues 90Y-DOTATOC and 177Lu-DOTATATE. These two most
commonly used radiopeptides, 90Y-DOTATOC and 177Lu-DOTATATE, produce overall objective
response rates of 15-35%. PRRT is generally well tolerated with mild toxicity, if the
necessary precautions, such as the co-administration of nephroprotective amino acids or the
adjustment of the administered activity, are taken.
The main aim of this study is to evaluate the safety and the efficacy of neoadjuvant PRRT
with 177Lu-DOTATATE followed by surgical resection for resectable non-functioning PanNETs at
high risk of recurrence.
The primary endpoint is the Rate of postoperative 90-day morbidity and mortality after
neoadjuvant PRRT with 177Lu-DOTATATE followed by pancreatic resection and the secondary
endpoints are:
1. Rate of objective radiological response to PRRT with 177Lu-DOTATATE according to
modified RECIST criteria (mRECIST)
2. Quality of life (QoL) after neoadjuvant PRRT followed by pancreatic surgical resection.
The study is designed as a prospective phase II single-arm trial. 8 Italian centers will
participate to the study (6 surgical sites, 2 nuclear medicine sites).
Patients will be recruited for 12 months. The study will end 2 months after operation of the
last patient enrolled and the total duration of the study will be 24 months.
Sample size estimation: 30 patients