RecruitingPhase 2NCT06345079

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

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


Sponsor

Australasian Gastro-Intestinal Trials Group

Enrollment

78 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial investigates whether patients with certain types of neuroendocrine tumors (slow-growing tumors that can arise in the gut or pancreas) can safely stop taking a long-term hormone injection medication (called somatostatin analogues, or SSAs) after receiving targeted radiation therapy directly to tumor cells (called PRRT — a type of internal radiation). **You may be eligible if...** - You are an adult (18+) with a well or moderately differentiated neuroendocrine tumor in the mid-gut, hind-gut, or pancreas that has spread and cannot be surgically removed - Your tumor has been growing despite SSA treatment - You have been on SSA injections (like octreotide or lanreotide) for at least 12 weeks - Your tumor shows somatostatin receptor expression on a specialized scan, making it suitable for PRRT - Your tumor has a low to moderate growth rate (Ki67 ≤ 20%) **You may NOT be eligible if...** - Your tumor does not show up on somatostatin receptor scans - Your tumors are not measurable on CT or MRI scans - You have very rapidly growing tumors (WHO grade 3) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCessation 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.

DRUGContinuation 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(17)

Royal North Shore Hospital

Sydney, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Royal Brisbane and Womens Hospital

Brisbane, Queensland, Australia

Cairns Hospital

Cairns, Queensland, Australia

Toowoomba Hospital

Toowoomba, Queensland, Australia

The Queen Elizabeth Hospital

Adelaide, South Australia, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Kalgoorlie Health Campus

Kalgoorlie-Boulder, Western Australia, Australia

Fiona Stanley Hospital

Perth, Western Australia, Australia

Cross Cancer Institute

Edmonton, Alberta, Canada

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

University Health Network Princess Margaret Cancer Centre

Toronto, 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

View Full Details on ClinicalTrials.gov

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NCT06345079


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