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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:
This study also has a compassionate purpose, which is to provide access to PRRT to patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized PRRT (P-PRRT) | Experimental | 177Lu-Octreotate (LuTate) P-PRRT will be administered as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-Octreotate | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression of disease is defined as the time from first cycle to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria. | Time from first cycle to date of disease progression or death, reported up to 5 years after accrual closure |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor radiation dose-response relationship | Correlation between cumulative absorbed radiation dose to tumor lesions and 3-month objective response rate, as defined above | 3 months after induction course |
| Tumor radiation dose-survival relationship |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Mathieu Beauregard, MD,MSc,FRCPC | CHU de Québec - Université Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Québec - Université Laval | Québec | Quebec | G1R 2J6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30506283 | Derived | 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. |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D002276 | Carcinoid Tumor |
| D018278 | Carcinoma, Neuroendocrine |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C554548 | 177Lu-octreotate |
| C447941 | lutetium Lu 177 dotatate |
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|
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| Overall survival (OS) |
| Time from first cycle to date of death, reported up to 5 years after accrual closure |
| Symptomatic response rate | Proportion of participants with improved, stable or worsened NET-related symptoms (frequency and severity), based on participant interviews at baseline and 3 months after completion of induction course. | 3 months after induction course |
| Quality of life response | Proportion of participants with improved, stable or worsened quality of life score by EORTC quality of life questionnaires QLQ-C30 and QLQ-GI.NET21, administered at baseline and 3 months after induction course. | 3 months after induction course |
| Biochemical response | Proportion of participants with improved (decreased by 25% or more), stable or worsened (increased by 25% or more) Chromogranin-A serum levels performed at baseline and 3 months after induction course. | 3 months after induction course |
| Safety determined by type, frequency and severity of adverse events per CTCAE version 4.03 and type, frequency and severity of laboratory toxicities per CTCAE version 4.03 | From the first treatment cycle administration until 5 years after accrual closure or death, whichever came first |
Correlation between cumulative absorbed radiation dose to tumor lesions and survival endpoints above (PFS and OS)
| At least 5 years after first cycle or until study completion, whichever came first |
| Renal radiation dose-chronic toxicity relationship | Correlation between cumulative absorbed radiation dose to kidney and variations in glomerular filtration rate from baseline, reported annually for at least 5 years after first cycle or until study completion. | At least 5 years after first cycle or until study completion, whichever came first |
| Bone marrow radiation dose-chronic toxicity relationship | Correlation between cumulative absorbed radiation dose to bone marrow and chronic variations of blood counts from baseline, reported annually for at least 5 years after first cycle or until study completion. | At least 5 years after first cycle or until study completion, whichever came first |
| Bone marrow radiation dose-subacute toxicity relationship | Correlation between per-cycle absorbed radiation dose to bone marrow and subacute variations (nadir values between 2 and 6 weeks) of blood counts from baseline, for each cycle. | Time of nadir blood counts values between 2 and 6 weeks after each cycle |
| D009380 | Neoplasms, Nerve Tissue |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |