Therapy for digestive and bronchopulmonary neuroendocrine tumours
Research type
Research Study
Full title
Peptide receptor radionuclide therapy (PRRT) in combination with lanreotide autogel: a retrospective study in progressive digestive and bronchopulmonary neuroendocrine tumours (PRELUDE).
IRAS ID
200783
Contact name
Zeina Saab
Contact email
Sponsor organisation
Ipsen Pharma
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
Neuroendocrine tumours (NETs) are slow-growing, heterogeneous neoplasms with a
malignant potential, arising from many different organs and tissues that share a common neuroendocrine phenotype. Due to the absence of symptoms in the early stage of the disease, NETs are difficult to diagnose, and this results in patients frequently diagnosed when presenting with advanced disease and poor prognosis.
This multicentre, international, retrospective, non comparative study PRELUDE is being performed to describe the use of Peptide receptor radionuclide therapy (PRRT) in combination with lanreotide autogel (LAN ATG) in subjects with progressive GEP-NET and BP-NET, and to assess the effectiveness of the combination regimen in terms of Progression-Free Survival (PFS) rate at the end of the last PRRT/LAN ATG cycle. Duration is 6 months (from the collection of the first subject data or the first signed informed consent, to the collection of the last subject data). Approximately 150 subjects will be enrolled in nine countries (Australia, Denmark, France, Germany, Italy, Netherlands, Poland, Sweden and United Kingdom).
No prospective assessment will be performed on the subjects during the study period; only existing data will be collected from the subjects’ medical records.
After confirmation of the subject’s eligibility by the site, subject’s data prior to the first PRRT/LAN ATG cycle (baseline), at the end of the last PRRT/LAN ATG cycle and at the last available follow-up visit up to 12 months post-treatment will be retrospectively collected.
Subject’s data will be collected from medical records and recorded into electronic case
report forms (eCRFs). The documentation of the radiological tumour assessments (CT or MRI, digital or print-out) will be prepared by the sites and provided to an independent radiologist for a central reading according to RECIST Version 1.1.
The primary effectiveness endpoint is the PFS rate at the end of the last PRRT/LAN ATG cycle will be assessed.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
16/LO/0494
Date of REC Opinion
21 Mar 2016
REC opinion
Favourable Opinion