Personalized PRRT of Neuroendocrine Tumors

NCT02754297 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: A14-11-2181
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors; Carcinoid Tumor; Carcinoma, Neuroendocrine

Keywords

Neuroendocrine tumors; Personalized; Peptide receptor radionuclide therapy; PRRT; 177Lu-DOTATATE; 177Lu-octreotate

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Primary efficacy endpoint is the objective response rate on contrast-enhanced CT (or MRI) by RECIST criteria (and secondarily by South Western Oncology Group (SWOG) criteria) at 3 months after the 4th induction cycle of P-PRRT, in comparison to pre-treatment scan (within 3 months before commencing P-PRRT).

  3 months after induction course

Secondary Outcomes (6)

• Progression-free survival (PFS)

  Time from first cycle to date of disease progression or death, reported up to 5 years after accrual closure

• Overall survival (OS)

  Time from first cycle to date of death, reported up to 5 years after accrual closure

• Symptomatic response rate

  3 months after induction course

• Quality of life response

  3 months after induction course

• Biochemical response

  3 months after induction course

Other Outcomes (5)

• Tumor radiation dose-response relationship

  3 months after induction course

• Tumor radiation dose-survival relationship

  At least 5 years after first cycle or until study completion, whichever came first

• Renal radiation dose-chronic toxicity relationship

  At least 5 years after first cycle or until study completion, whichever came first

Study Arms (1)

Personalized PRRT (P-PRRT)

EXPERIMENTAL

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).

Drug: 177Lu-Octreotate

Interventions

177Lu-Octreotate 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.

Also known as: LuTate, 177Lu-[DOTA0,Tyr3]octreotate, 177Lu-DOTATATE

Personalized PRRT (P-PRRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

CHU de Québec - Université Laval

Québec, Quebec, G1R 2J6, Canada

Location

Related Publications (1)

• 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.

  PMID: 30506283 DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors; Carcinoid Tumor; Carcinoma, Neuroendocrine

Interventions

177Lu-octreotate; lutetium Lu 177 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Study Officials

• Jean-Mathieu Beauregard, MD,MSc,FRCPC

  CHU de Québec - Université Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: April 28, 2016
• Study Start: April 12, 2016
• Primary Completion: April 12, 2025
• Study Completion (Estimated): April 12, 2029
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)