Cessation of Somatostatin Analogues After PRRT in Mid, Hind-Gut and Pancreatic Neuroendocrine Tumours — STOPNET  

Neuroendocrine Tumors Clinical Trial

Official title: A Randomised Study of Cessation of Somatostatin Analogues After Peptide Receptor Radionuclide Therapy in Mid, Hind-Gut and Pancreatic Neuroendocrine Tumours (STOPNET)

Status Not yet recruiting

Clinical Trial Summary

Neuroendocrine tumours (NETs) are slow growing cancers, which commonly present as metastatic incurable disease. Some neuroendocrine tumours, termed functional NETs, overproduce hormones which result in a variety of symptoms. However, approximately 75% of NETs are considered non-functional meaning that they do not result in hormone overproduction. The main treatment for both functional and non-functional NETs is somatostatin analogues (SSA, a type of inhibitory hormone). These drugs slow tumour growth and reduce hormone production. Over time, the majority of patients will experience tumour growth despite treatment with SSA therapy. When this occurs, the addition of Peptide Receptor Radionuclide Therapy (PRRT, a type of targeted radiotherapy) in combination with ongoing SSA therapy is given. However, it is not known if continuing SSA therapy after commencement of PRRT is beneficial or not.

The aim of this study is to estimate the outcomes of patients with grade 1 and 2 well differentiated mid, hind-gut or pancreatic neuroendocrine tumours who have progressed on SSA therapy and receive subsequent PRRT with or without concurrent SSA.

Clinical Trial Description

Neuroendocrine tumours commonly originate from the gut and metastasise widely including to the liver, lymph nodes and bones. Originally called "carcinoid tumours", these cancers are most commonly treated with somatostatin analogues (SSA) first line. These analogues treat carcinoid syndrome and slow tumour growth. Despite SSA therapy, progression develops over time. Upon progression, peptide receptor radionuclide therapy (PRRT) is the next standard therapeutic option. After PRRT is initiated, it is unclear if continuing SSA injections is beneficial. There are reasons to believe it might be necessary to continue SSAs, but other reasons to believe they should cease. Given that SSA injections are expensive and associated with side effects, this study aims to clarify the utility of continuing SSA injections after progression on SSA therapy and commencement of PRRT.

STOPNET aims to explore outcomes in grade 1 and 2 mid, hind gut or pancreatic neuroendocrine tumours, that have progressed on SSA therapy, are eligible to receive PRRT and in whom the SSA is either continued or ceased after PRRT is commenced.

The two primary objectives include

1. To estimate the 20-month progression free survival rate after PRRT commencement in patients who cease and who continue SSA.

2. Feasibility as measured by:

1. Recruitment rate and

2. Patient acceptance of ceasing and staying off SSA over the 20 month follow up period.

The study design of STOPNET is prospective, randomised, non-comparative, open label, multicentre phase II study. Patients meeting the inclusion and exclusion criteria will be randomised, prior to commencing PRRT, to either continue or cease SSA treatment. Randomisation will occur centrally in REDCap by the AGITG STOPNET study team. Randomisation will be 2:1 (the majority being randomised to cease SSA) and will be stratified by WHO tumour grade (1 V 2), sites of metastases (visceral only verse visceral and bone) and institution. ;

Related Conditions & MeSH terms

• Neuroendocrine Tumors

• NCT number: NCT06345079
• Study type: Interventional
• Source: Australasian Gastro-Intestinal Trials Group
• Contact: Laura Carolan
• Phone: +61 2 7208 2710
• Email: agitg_stopnet_mailbox@gicancer.org.au
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Completion date: June 2028