Clinical trials and guidelines

Clinical trials (see also Clinical guidelines...)

UKI NETS is currently undertaking some multi-centre studies.  The following is for information only and does not represent the definitive version of the trial protocol.

  Sponsor Trial phase Trial design Target population Primary end pt No. pts
SIG-NET Efficacy and Safety of pasireotide (SOM230) LAR vs octreotide LAR in carcinoid syndrome
SIG-NET Clinical Study Summary (pdf) (621kb)		 Novartis, Phase III octreotide 60mg vs pasireotide 40mg Patients with metastatic carcinoid tumours whose disease related symptoms are inadequately controlled by somatostatin analogues (30mg octreotide/120mg lanreotide Autogel) Reduction in number of bowel movements and flushing episodes 150
RAMSETE
(RAD001 in Advanced Metastatic Silent NeuroEndocrine Trial in Europe)(pdf)(70kb)		 Novartis, Phase II RAD001 open label, single arm. Advanced resectable or metastatic, non syndromic non functional NET (low or intermediate grade) from foregut, midgut and hindgut with exclusion of pancreatic NET Complete Response
Partial Response
(RECIST criteria)		 60
Lanreotide Autogel vs placebo in non-functioning gastroenteropancreatic NETS Ipsen Phase III Lanreotide autogel 120 mg vs placebo Non-functional Entero-pancreatic or Unknown primary PFS 200

NET01 – Chemotherapy in metastatic pancreatic NETS and NETS of unknown origin (NCRI adopted) (pdf) (20kb)

NET01 Newsletter January 2008 (pdf) (88kb)

 Cambridge Randomised Phase II Cap-strep vs Cap-Cist Foregut, unknown primary,Progressing disease PFS 84
RADIANT-4 Novartis RADIANT-4 Phase III A multi-centre, randomized, double-blind, placebo-controlled, phase III study of RAD001 in combination with SOM230 LAR versus RAD001+placebo in patients with advanced pancreatic neuroendocrine tumour (PNET)-RADIANT-4 Advanced (unresectable or metastatic) low to intermediate grade histologically confirmed pancreatic neuroendocrine tumour (PNET) PFS  564

Further studies are planned involving the use of newer agents including RAD001, antiangiogenic agents, and radionucleotide therapy.

Clinical guidelines

Guidelines for the management of gastroenteropancreatic neuroendocrine (including carcinoid) tumours