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The study terminated prematurely due to insufficient recruitment.
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The objective of the PRELUDE study is to describe the use of lanreotide Autogel® (LAN ATG) combined with Peptide Receptor Radionuclide Therapy (PRRT) in the treatment of progressive neuroendocrine tumours located in the lung or in the digestive system as there is currently limited data on these treatments used together for these types of neuroendocrine tumours.
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) rate according to the central reading using RECIST (Version 1.1) | Approximately 3 to 6 months after the last PRRT/LAN ATG cycle |
| Measure | Description | Time Frame |
|---|---|---|
| PFS rate as per RECIST (Version 1.1) | Up to 12 months post-treatment | |
| Best Overall Response as per RECIST (Version 1.1) | Baseline, until disease progression or end of treatment period (generally 3 to 6 months after the last PRRT/LAN ATG cycle) whichever is earlier |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter MacCallum Cancer Centre | East Melbourne | Australia | ||||
| IUCT Oncopole |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32062681 | Derived | Prasad V, Srirajaskanthan R, Toumpanakis C, Grana CM, Baldari S, Shah T, Lamarca A, Courbon F, Scheidhauer K, Baudin E, Truong Thanh XM, Houchard A, Dromain C, Bodei L. Lessons from a multicentre retrospective study of peptide receptor radionuclide therapy combined with lanreotide for neuroendocrine tumours: a need for standardised practice. Eur J Nucl Med Mol Imaging. 2020 Sep;47(10):2358-2371. doi: 10.1007/s00259-020-04712-2. Epub 2020 Feb 15. |
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| Objective Response Rate as per RECIST (Version 1.1) | Approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment |
| Change from baseline (i.e. from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in the presence and in the severity of diarrhoea and flushing, if any | Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment |
| Change from baseline (i.e. from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in the tumour biomarker CgA | Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle |
| Change from baseline (ie from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in body weight | Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment |
| Incidence of nephrotoxicity, haematotoxicity and hepatotoxicity events (based on a predefined list of disorders) | Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment |
| Incidence of vomiting (during infusion only) | Approximately 3 to 6 months after the last PRRT/LAN ATG cycle |
| Toulouse |
| France |
| Institut Gustave Roussy | Villejuif | France |
| Zentralklinil Bad Berka | Bad Berka | Germany |
| Charité | Berlin | Germany |
| Klinikum rechts der Usar | München | Germany |
| Unversità degli Studi di Messina | Messina | Italy |
| IEO Institutio Europeo di Oncologia | Milan | Italy |
| Queen Elizabeth Hospital Birmingham | Birmingham | United Kingdom |
| Kings College Hospital | London | United Kingdom |
| Royal Free Hospital London | London | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | United Kingdom |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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