Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Retrospective Data Analysis of Therapy With PRRT Combined With Lanreotide Autogel® for Neuroendocrine Tumours (PRELUDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02788578
Recruitment Status : Terminated (The study terminated prematurely due to insufficient recruitment.)
First Posted : June 2, 2016
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date May 27, 2016
First Posted Date June 2, 2016
Last Update Posted Date December 21, 2018
Actual Study Start Date June 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2016)
Progression Free Survival (PFS) rate according to the central reading using RECIST (Version 1.1) [ Time Frame: Approximately 3 to 6 months after the last PRRT/LAN ATG cycle ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 27, 2016)
  • PFS rate as per RECIST (Version 1.1) [ Time Frame: Up to 12 months post-treatment ]
  • Best Overall Response as per RECIST (Version 1.1) [ Time Frame: Baseline, until disease progression or end of treatment period (generally 3 to 6 months after the last PRRT/LAN ATG cycle) whichever is earlier ]
  • Objective Response Rate as per RECIST (Version 1.1) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Approximately 3 to 6 months after the last PRRT/LAN ATG cycle ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community sample
Condition Neuroendocrine Tumours
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: October 27, 2017)
40
Original Estimated Enrollment
 (submitted: May 27, 2016)
150
Actual Study Completion Date July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   France,   Germany,   Italy,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02788578
Other Study ID Numbers F-FR-52030-344
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date December 2018