Clinical trial NCT02788578: A Retrospective Data Analysis of Therapy With PRRT Combined With Lanreotide Autogel® for Neuroendocrine Tumours
Official title: Peptide Receptor Radionuclide Therapy (PRRT) in Combination With Lanreotide Autogel: A Retrospective Study in Progressive Digestive and Bronchopulmonary Neuroendocrine Neuroendocrine Tumours
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neuroendocrine Tumours
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2016-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Histopathologically confirmed metastatic well differentiated Neuroendocrine Tumour (NET) (Grade G1 or G2 according to the World Health Organisation 2010 classification): Gastro-entero-pancreatic (GEP) or Bronchopulmonary (BP) primary tumour, or tumour of unknown origin believed to be of GEP origin, if a primary tumour elsewhere was excluded by multiphasic computerised tomography (CT) or magnetic resonance imaging (MRI)
* Disease progression radiologically documented with evaluable imaging (CT or MRI, digital or print-out), performed within 12 months and within 6 months prior to the first PRRT/LAN ATG cycle
* Metastatic- or locally-advanced, hormonal functioning or nonfunctioning GEP-NET or BP-NET;
* Confirmed presence of Somatostatin Receptors (SSTRs) on all target lesions based on positive SSTR scintigraphy (Octreoscan®/99mTC-tektrotyd) or 68Ga SSTR Positron Emission Tomography-Computerised Tomography (PET/CT) imaging, i.e. Grade ≥2 respectively per the Krenning scale or per the modified Krenning scale

Exclusion Criteria:

* Absence of information regarding LAN ATG treatment: dose received, start date, frequency of injections
* No CT or MRI within 12 months and within 6 months preceding the baseline, or at the end of the last PRRT/LAN ATG cycle
* Absence of information on cumulative activity of PRRT with 177 Lutetium (177Lu) DOTATOC or 177Lu-DOTATATE received (at least 500 mCi (equivalent to 18.5 GBq), for the entire therapy)
* PRRT prior to the first combination cycle of PRRT/LAN ATG

Primary outcomes:
measure: Progression Free Survival (PFS) rate according to the central reading using RECIST (Version 1.1)
timeFrame: Approximately 3 to 6 months after the last PRRT/LAN ATG cycle
Secondary outcomes:
measure: PFS rate as per RECIST (Version 1.1)
timeFrame: Up to 12 months post-treatment
measure: Best Overall Response as per RECIST (Version 1.1)
timeFrame: Baseline, until disease progression or end of treatment period (generally 3 to 6 months after the last PRRT/LAN ATG cycle) whichever is earlier
measure: Objective Response Rate as per RECIST (Version 1.1)
timeFrame: Approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment
measure: 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
timeFrame: Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment
measure: Change from baseline (i.e. from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in the tumour biomarker CgA
timeFrame: Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle
measure: Change from baseline (ie from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in body weight
timeFrame: Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment
measure: Incidence of nephrotoxicity, haematotoxicity and hepatotoxicity events (based on a predefined list of disorders)
timeFrame: Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment
measure: Incidence of vomiting (during infusion only)
timeFrame: Approximately 3 to 6 months after the last PRRT/LAN ATG cycle
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Toulouse
country: France
facility: IUCT Oncopole
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Bad Berka
country: Germany
facility: Zentralklinil Bad Berka
city: Berlin
country: Germany
facility: Charité
city: München
country: Germany
facility: Klinikum rechts der Usar
city: Messina
country: Italy
facility: Unversità degli Studi di Messina
city: Milano
country: Italy
facility: IEO Institutio Europeo di Oncologia
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital London
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.