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RECRUITING
NCT06345079
PHASE2

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

Sponsor: Australasian Gastro-Intestinal Trials Group

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2024-10-14

Completion Date

2028-06

Last Updated

2025-08-14

Healthy Volunteers

No

Interventions

DRUG

Cessation of somatostatin analogues

Patients randomised to cease SSA will receive their last SSA injection ≥28 days prior to their first cycle of PRRT and will remain off SSA for the duration of the study. If there is concern from the treating team that a patient may experience a carcinoid flare after PRRT, then short acting octreotide is allowed to be used to control any symptoms.

DRUG

Continuation of somatostatin analogues

Patients randomised to continue SSA will receive a SSA injection ≥28 days prior to their first cycle of PRRT, during PRRT and will continue receiving SSA every 4 weeks after PRRT.

Locations (12)

Royal North Shore Hospital

Sydney, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Royal Brisbane and Womens Hospital

Brisbane, Queensland, Australia

The Queen Elizabeth Hospital

Adelaide, South Australia, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Perth, Western Australia, Australia

BC Cancer Agency, Vancouver Cancer Centre

Vancouver, British Columbia, Canada

London Health Sciences Centre Research Institute (LHSCRI)

London, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Odette Cancer Centre Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada