REMINET
Research type
Research Study
Full title
A European, multicentre, phase II/III randomised double-blind, placebo controlled study evaluating Lanreotide as maintenance therapy in patients with non-resectable duodeno-pancreatic neuroendocrine tumours after first-line treatment
IRAS ID
165227
Contact name
Juan Valle
Contact email
Sponsor organisation
Federation Francophone de Cancerologie Digestive (FFCD)
Eudract number
2013-004069-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 8 months, 1 days
Research summary
This study is to investigate the effectiveness of Lanreotide as a maintenance therapy for patients with non-resectable duodeno-pancreatic neuroendocrine tumours who have shown a good response to first-line treatment. Normally at this stage, the patients would have routine monitoring with no treatment but study patients will be randomised to receive monthly injections of placebo or Lanreotide, to compare the progression of disease in the two groups. Previous studies with Lanreotide suggest that this treatment can stabilise tumour growth and therefore increase the time to disease progression.
Patients recruited to the study will have an injection of Lanreotide/placebo every 28 days with study assessments every 3 months including blood analyses, tumour assessments by CT/MRI and bone scan, physical examination and quality of life questionnaires. If progression occurs, treatment will stop and the patient will be followed up every 6 months with simplified assessments and without further CT/MRI and bone scans.
Initially, patients will be recruited into Phase II, where minimum follow-up is for 12 months but, depending on results, the study may continue into Phase III where the follow-up period is 10 years.
The research study is being organised and funded by Fédération Francophone de Cancérologie Digestive (FFCD), France. FFCD is an association of health professionals. The goals of the association are training and research in digestive oncology.
There will be two sites in the UK, in London and Manchester.REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0108
Date of REC Opinion
20 Feb 2015
REC opinion
Favourable Opinion