Personalized PRRT of Neuroendocrine Tumors (P-PRRT)

Laval University

Status and phase: Active, not recruiting; Phase 2

Conditions: Carcinoid Tumor; Neuroendocrine Tumors; Carcinoma, Neuroendocrine

Treatments: Drug: 177Lu-Octreotate

Study type: Interventional

Funder types: Other

Identifiers

NCT02754297

A14-11-2181

Details and patient eligibility

About

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.

Full 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.

Enrollment: 275 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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275 participants in 1 patient group

Personalized PRRT (P-PRRT)

Experimental group

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).

Treatment:

Drug: 177Lu-Octreotate