Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02788578




Registration number
NCT02788578
Ethics application status
Date submitted
27/05/2016
Date registered
2/06/2016
Date last updated
21/12/2018

Titles & IDs
Public title
A Retrospective Data Analysis of Therapy With PRRT Combined With Lanreotide Autogel® for Neuroendocrine Tumours
Scientific title
Peptide Receptor Radionuclide Therapy (PRRT) in Combination With Lanreotide Autogel: A Retrospective Study in Progressive Digestive and Bronchopulmonary Neuroendocrine Neuroendocrine Tumours
Secondary ID [1] 0 0
F-FR-52030-344
Universal Trial Number (UTN)
Trial acronym
PRELUDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine Tumours 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) rate according to the central reading using RECIST (Version 1.1)
Timepoint [1] 0 0
Approximately 3 to 6 months after the last PRRT/LAN ATG cycle
Secondary outcome [1] 0 0
PFS rate as per RECIST (Version 1.1)
Timepoint [1] 0 0
Up to 12 months post-treatment
Secondary outcome [2] 0 0
Best Overall Response as per RECIST (Version 1.1)
Timepoint [2] 0 0
Baseline, until disease progression or end of treatment period (generally 3 to 6 months after the last PRRT/LAN ATG cycle) whichever is earlier
Secondary outcome [3] 0 0
Objective Response Rate as per RECIST (Version 1.1)
Timepoint [3] 0 0
Approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment
Secondary outcome [5] 0 0
Change from baseline (i.e. from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in the tumour biomarker CgA
Timepoint [5] 0 0
Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle
Secondary outcome [6] 0 0
Change from baseline (ie from Day 1 of the first PRRT/LAN ATG cycle prior to any administration) in body weight
Timepoint [6] 0 0
Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment
Secondary outcome [7] 0 0
Incidence of nephrotoxicity, haematotoxicity and hepatotoxicity events (based on a predefined list of disorders)
Timepoint [7] 0 0
Baseline, approximately 3 to 6 months after the last PRRT/LAN ATG cycle and up to 12 months post-treatment
Secondary outcome [8] 0 0
Incidence of vomiting (during infusion only)
Timepoint [8] 0 0
Approximately 3 to 6 months after the last PRRT/LAN ATG cycle

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2017
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Toulouse
Country [2] 0 0
France
State/province [2] 0 0
Villejuif
Country [3] 0 0
Germany
State/province [3] 0 0
Bad Berka
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
München
Country [6] 0 0
Italy
State/province [6] 0 0
Messina
Country [7] 0 0
Italy
State/province [7] 0 0
Milano
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Birmingham
Country [9] 0 0
United Kingdom
State/province [9] 0 0
London
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02788578
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02788578