Actively Recruiting
Cessation of Somatostatin Analogues After PRRT in Mid, Hind-Gut and Pancreatic Neuroendocrine Tumours
Led by Australasian Gastro-Intestinal Trials Group · Updated on 2025-08-14
78
Participants Needed
12
Research Sites
189 weeks
Total Duration
On this page
Sponsors
A
Australasian Gastro-Intestinal Trials Group
Lead Sponsor
C
Canadian Cancer Trials Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cessation of Somatostatin Analogues After PRRT in Mid, Hind-Gut and Pancreatic Neuroendocrine Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years with well or moderately differentiated midgut, hindgut, or pancreatic neuroendocrine tumors that are metastatic, inoperable, and progressing despite SSA treatment
- Measurable disease on triphasic CT or MRI as per RECIST 1.1
- Ki67 index of 20% or less and mitotic count up to 20 per high power field (WHO grade 1 or 2)
- Receiving growth-controlling doses of SSA for at least 12 weeks prior to study entry (minimum 30 mg octreotide or 120 mg lanreotide monthly)
- Somatostatin receptor expression suitable for PRRT as shown by SSTR PET scan
- PRRT deemed the next appropriate treatment step by clinician or NET multidisciplinary team
- ECOG performance status of 0 to 2
- Willingness to provide written informed consent and comply with study requirements
- Adequate kidney, liver, and blood function as assessed by the treating team
- Life expectancy of at least 12 months
- Optional availability of tissue or blood samples for translational research
- Non-functioning NET by clinical assessment and defined by low 24-hour urine 5HIAA (less than 1.5 times upper limit of normal) for mid and hindgut tumors
- No history of dose escalation or short-acting SSA use for hormone-related symptoms
- No significant carcinoid heart disease and safe to proceed with PRRT based on echocardiogram within 26 weeks
You will not qualify if you...
- NETs of the stomach or lung
- Receiving SSA doses lower than standard growth-control doses or on SSA for less than 3 months
- Prior chemotherapy or targeted therapy (e.g., everolimus); prior local therapies allowed
- Contraindications to PRRT as per local guidelines
- Pregnancy or lack of required contraception for patients of childbearing potential
- Prior PRRT treatment or re-treatment
- Uncontrolled central nervous system metastases; must be off corticosteroids for at least 2 weeks
- Inability to comply with study assessments or follow-up due to social, psychological, or geographic reasons
- Poorly controlled concurrent medical illnesses that interfere with study participation
- Concurrent or prior malignancies that may affect study assessments or outcomes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Actively Recruiting
2
Wollongong Hospital
Wollongong, New South Wales, Australia, 2502
Actively Recruiting
3
Royal Brisbane and Womens Hospital
Brisbane, Queensland, Australia, 4006
Actively Recruiting
4
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
5
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
6
Fiona Stanley Hospital
Perth, Western Australia, Australia, 6150
Actively Recruiting
7
BC Cancer Agency, Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
8
London Health Sciences Centre Research Institute (LHSCRI)
London, Ontario, Canada, N6A 5W9
Actively Recruiting
9
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 1J8
Actively Recruiting
10
Odette Cancer Centre Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, TG 260
Actively Recruiting
11
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Actively Recruiting
12
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H
Actively Recruiting
Research Team
J
Julia Kuszewski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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