Personalized PRRT of Neuroendocrine Tumors

NCT ID: NCT02754297

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-12
• Study Completion Date: 2029-04-12

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.

Conditions

Neuroendocrine Tumors; Carcinoid Tumor; Carcinoma, Neuroendocrine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Personalized PRRT (P-PRRT)

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).

Group Type: EXPERIMENTAL

177Lu-Octreotate

Intervention Type: DRUG

• The induction course will consist in 4 cycles at 8-10 weeks intervals.
• Concomitant amino acids will be administered for renal protection.
• Intra-arterial LuTate administration will be allowed in suitable cases.
• Dosimetry will be based on quantitative SPECT/CT imaging.
• In patients with hormonal symptoms, somatostatine analogues can be given between P-PRRT cycles.

Interventions

177Lu-Octreotate

• The induction course will consist in 4 cycles at 8-10 weeks intervals.
• Concomitant amino acids will be administered for renal protection.
• Intra-arterial LuTate administration will be allowed in suitable cases.
• Dosimetry will be based on quantitative SPECT/CT imaging.
• In patients with hormonal symptoms, somatostatine analogues can be given between P-PRRT cycles.

Intervention Type: DRUG

Other Intervention Names

LuTate; 177Lu-[DOTA0,Tyr3]octreotate; 177Lu-DOTATATE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Mathieu Beauregard, MD,MSc,FRCPC

Role: PRINCIPAL_INVESTIGATOR

CHU de Québec - Université Laval

Locations

CHU de Québec - Université Laval

Québec, Quebec, Canada

Countries

Canada

References

Del Prete M, Buteau FA, Arsenault F, Saighi N, Bouchard LO, Beaulieu A, Beauregard JM. Personalized 177Lu-octreotate peptide receptor radionuclide therapy of neuroendocrine tumours: initial results from the P-PRRT trial. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):728-742. doi: 10.1007/s00259-018-4209-7. Epub 2018 Nov 30.

Reference Type: DERIVED

PMID: 30506283 (View on PubMed)

Other Identifiers

A14-11-2181

Identifier Type: -

Identifier Source: org_study_id