Personalized PRRT of Neuroendocrine Tumors

Last updated: August 20, 2024
Sponsor: CHU de Quebec-Universite Laval
Overall Status: Active - Not Recruiting

Phase

2

Condition

Abdominal Cancer

Neoplasms

Carcinoid Syndrome And Carcinoid Tumours

Treatment

177Lu-Octreotate

Clinical Study ID

NCT02754297
A14-11-2181
  • Ages > 18
  • All Genders

Study Summary

In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate) will be personalized, i.e. administered activity of LuTate will be tailored for each patient to maximize absorbed radiation dose to tumor, while limiting that to healthy organs.

The purpose of this study is to:

  • Assess the objective (radiological), symptomatic and biochemical response rates following an induction course of personalized PRRT;

  • Assess the overall, the disease-specific, and the progression-free survival following P-PRRT;

  • Correlate therapeutic response and survival with tumor absorbed radiation dose;

  • Evaluate the acute, subacute and chronic adverse events following P-PRRT;

  • Correlate toxicity (i.e. occurence and severity of adverse events) with absorbed radiation doses to organs at risk;

  • Optimize the quantitative SPECT imaging-based dosimetry methods in a subset of 20 patients (sub-study funded by the Canadian Institutes of Health Research).

This study also has a compassionate purpose, which is to provide access to PRRT to patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient suffering from a progressive and/or symptomatic NET (any site);

  • Patient ineligible to, or refusing a potentially curative treatment such as surgicalresection;

  • Patient who did not respond, is intolerant or refuses other indicated and availablepalliative treatments;

  • Demonstration of overexpression of somatostatin receptor by tumor lesions byscintigraphic imaging (Octreoscan or 68Ga positron emission tomography.

Exclusion

Exclusion Criteria:

  • Pregnancy;

  • Breastfeeding;.

  • Very limited survival prognosis (i.e. less than a few weeks, because of the NETdisease or any other condition) or Eastern Cooperative Oncology Group (ECOG) 4performance status;

  • Inability to obtain informed consent of the participant.

Study Design

Total Participants: 275
Treatment Group(s): 1
Primary Treatment: 177Lu-Octreotate
Phase: 2
Study Start date:
April 12, 2016
Estimated Completion Date:
April 12, 2029

Study Description

A prospective, single-center, non-comparative, open phase 2 study. In this study, personalized peptide receptor radionuclide therapy (P-PRRT) with 177Lu-Octreotate (LuTate) will be administered to patients with progressive and/or symptomatic inoperable neuroendocrine tumors (NET) of any origin expressing the somatostatin receptor.

The primary objective to assess the objective response rate at 3 months following a four-cycle induction course of P-PRRT will be assessed for at least the first 85 participants.

This study as a compassionate aim to provide access to personalized PRRT patients at CHU de Québec - Université Laval center, and therefore this study has no pre-determined recruitment period duration or limited number of participants, and may remain open as long as necessary to fulfill this aim.

The study will continue until all participants have completed a minimum follow-up of 5 years. Interim analyses will be conducted annually.

Connect with a study center

  • CHU de Québec - Université Laval

    Quebec City, Quebec G1R 2J6
    Canada

    Site Not Available

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