Personalized PRRT of Neuroendocrine Tumors

Phase 2

Active, not recruiting

• Conditions: Neuroendocrine Tumors; Carcinoid Tumor; Carcinoma, Neuroendocrine

• Registration Number: NCT02754297
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-3-10
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Patient suffering from a progressive and/or symptomatic NET (any site);<br><br> - Patient ineligible to, or refusing a potentially curative treatment such as surgical<br> resection;<br><br> - Patient who did not respond, is intolerant or refuses other indicated and available<br> palliative treatments;<br><br> - Demonstration of overexpression of somatostatin receptor by tumor lesions by<br> scintigraphic imaging (Octreoscan or 68Ga positron emission tomography.<br><br>Exclusion Criteria:<br><br> - Pregnancy;<br><br> - Breastfeeding;.<br><br> - Very limited survival prognosis (i.e. less than a few weeks, because of the NET<br> disease or any other condition) or Eastern Cooperative Oncology Group (ECOG) 4<br> performance status;<br><br> - Inability to obtain informed consent of the participant.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS);Overall survival (OS);Symptomatic response rate;Quality of life response;Biochemical response;Safety determined by type, frequency and severity of adverse events per CTCAE version 4.03 and type, frequency and severity of laboratory toxicities per CTCAE version 4.03