Personalized PRRT of Neuroendocrine Tumors

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Brief Title

Personalized PRRT of Neuroendocrine Tumors

Official Title

Personalized Peptide Receptor Radionuclide Therapy of Neuroendocrine Tumors: A Phase 2 Study

Brief 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.
    

Detailed 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective response rate (ORR)

Secondary Outcome

 Progression-free survival (PFS)

Condition

Neuroendocrine Tumors

Intervention

177Lu-Octreotate

Study Arms / Comparison Groups

 Personalized PRRT (P-PRRT)
Description:  177Lu-Octreotate (LuTate) P-PRRT will be administered as follows:
Renal absorbed radiation dose will be prescribed for the 4-cycle induction course (23 Gy) and for each subsequent cycle (6 Gy), with a reduction in cases of impaired renal or bone marrow function, or significant toxicity from prior cycles.
The personalized activity to be administered at each cycle will be derived from renal dose per unit of injected activity that is predicted by patient characteristics or renal dose delivered during prior cycle(s).
Participants responding to the induction course of P-PRRT will be eligible to receive additional consolidation and/or maintenance cycles.
Participants with prior PRRT exposure outside the trial may receive less induction cycles, or only consolidation/maintenance cycle(s).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

300

Start Date

April 12, 2016

Completion Date

December 2026

Primary Completion Date

April 2021

Eligibility Criteria

        Inclusion Criteria:

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

          -  Patient ineligible to, or refusing a potentially curative treatment such as surgical
             resection;

          -  Patient who did not respond, is intolerant or refuses other indicated and available
             palliative treatments;

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

        Exclusion Criteria:

          -  Pregnancy;

          -  Breastfeeding;.

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

          -  Inability to obtain informed consent of the participant.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jean-Mathieu Beauregard, MD,MSc,FRCPC, 418-525-4444, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02754297

Organization ID

A14-11-2181


Responsible Party

Sponsor

Study Sponsor

CHU de Quebec-Universite Laval


Study Sponsor

Jean-Mathieu Beauregard, MD,MSc,FRCPC, Principal Investigator, CHU de Québec - Université Laval


Verification Date

July 2020