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Neoadjuvant PRRT With 177Lu-DOTATATE Followed by Surgery for Resectable PanNET

NCT04385992 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-06-27

No results posted yet for this study

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 RECIST criteria (version 1.1), for primary lesions' assessment, and modified RECIST criteria (mRECIST), for liver metastases' assessment, if detected
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

Conditions

Interventions

DRUG

177Lu-Dotatate

Peptide Receptor Radionuclide Therapy (PRRT) is based on specific somatostatin receptor targeting with radiolabelled analogues 90Y-DOTATOC and 177Lu-DOTATATE

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Massimo Falconi, Professor · Ospedale San Raffaele IRCCS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-09
Primary Completion
2023-01-25
Completion
2023-06-26

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04385992 on ClinicalTrials.gov