Neuroendocrine tumours (NETs) are a heterogeneous group of malignancies that can arise at any site in the gastrointestinal tract, that are known by their ability to over express somatostatin receptors.  Originally called carcinoid tumours, these tumours are rising in incidence. In patients with incurable disease, several systemic options have demonstrated activity but few have been compared in prospective, randomised controlled trials (RCTs).  177Lu-Octreotate peptide receptor radionuclide therapy (PRRT) and capecitabine and temozolomide (CAPTEM) have shown promising activity in initial single arm trials. 

CONTROL NETs is two non-comparative parallel group phase II randomised open label trials of PRRT and CAPTEM in two cohorts of NET patients.  Cohort A is comprised of patients with low to intermediate grade pancreatic neuroendocrine tumours (pNETs) randomised to receive PRRT + CAPTEM or CAPTEM alone.  Cohort B is comprised of patients with low to intermediate grade midgut neuroendocrine tumours (mNETs) randomised to receive PRRT + CAPTEM or PRRT alone.  In Cohort A, pNETS, the control arm is CAPTEM and in Cohort B, mNETs the control arm is PRRT. The randomised design with a reference control arm is required due to the heterogeneity in historical data for this study population.

Aspects of trial design and conduct will be presented with regards the particular challenges of conducting research in rare tumours.

Dr Sjoquist is presenting on behalf of the CONTROL NET study group.

This study is a collaboration between the AGITG and the NHMRC Clinical Trials Centre, University of Sydney