Neuroendocrine TumorsPhase 2STOPNETNCT06345079
Cessation of Somatostatin Analogues After PRRT in Mid, Hind-Gut and Pancreatic Neuroendocrine Tumours
A Phase 2 study testing Cessation of somatostatin analogues and Continuation of somatostatin analogues in people with Neuroendocrine Tumors, run by Australasian Gastro-Intestinal Trials Group at 17 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Cessation of somatostatin analogues and Continuation of somatostatin analogues
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 14 Oct 2024to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years of age with well or moderately differentiated mid or hindgut neuroendocrine tumour, or pancreatic neuroendocrine tumour, metastatic and inoperable, demonstrating progression despite SSA treatment of sufficient disease magnitude to warrant PRRT as determined by the treating clinician and/or the NET Multidisciplinary Team (MDT).
- Must have measurable disease on triphasic CT/MRI as per RECIST 1.1.
- Ki67 ≤ 20% AND mitotic count 20 per HPF (i.e., WHO grade 1 or 2)
- Patient has been receiving growth-controlling doses of SSA for at least 12 weeks prior to study entry. This is a minimum of 30 mg Octreotide or120mg lanreotide monthly.
- Uptake on SSTR PET scan demonstrating somatostatin receptor expression that is suitable for PRRT as judged by the clinical team. FDG PET scans are to be done at the judgement of the treating team and are not required for enrolment into this study.
- PRRT is deemed the most appropriate next treatment step (i.e., patient is inoperable, and liver directed therapies are not preferred)
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- ECOG performance status 0 -2
- Written informed consent. Patients must be willing to either cease or continue SSA, depending on which study arm they are randomised to. Patients must be willing to comply with all other study requirements
- Adequate renal, hepatic and haematologic function as judged by the treating team
- Life expectancy of at least 12 months
- Availability of tissue from resection or biopsy samples is desired but is not mandatory for study inclusion. Tissues will only be retrieved if the patient consents to optional translational research sample collection. Similarly, bloods for research purposes will only be collected from those patients who consent to optional translational research sample collection.
- Non-functioning NET: SSA treatment will have been commenced for control of tumour growth and not for carcinoid or other hormone overproduction syndrome, as judged by the clinician and/or NET MDT. Non-functioning NET is judged by the treating clinical team based on patient symptomatology. In addition, for this study, non-functioning tumour is defined as:
- 24-hour urine 5-hydroxyindoleacetic acid (5HIAA) of <1.5x upper limit of normal (applies to mid and hind gut patients only).
- Please note: routine measurement of gastrin, insulin, C-peptide levels, glucagon etc. is not required unless clinically indicated.
- Never had escalation of the SSA treatment dose to control carcinoid carcinoid or other hormone-related symptoms
- Never required short acting SSA treatment to control carcinoid carcinoid or other hormone-related symptoms
- No significant carcinoid induced valvular heart disease IE: Echocardiogram to be done in all patients within 26 weeks of study enrolment and deemed safe to proceed with PRRT by the treating team.
Who cannot join
- This study is for pancreatic, mid-gut and hind-gut NET only. Gastric and lung NETs are excluded
- Any patient on an SSA dose lower than the standard growth-control dose. Patients must have been on octreotide 30 mg or lanreotide 120 mg for at least 3 months prior to study entry.
- Prior chemotherapy or targeted therapy (e.g., everolimus). Patients who have received prior local therapy, including external beam radiotherapy and liver directed therapy prior to or during SSA therapy are eligible.
- Any contraindication to PRRT, as per local institutional practice.
- Pregnancy. For female patients of childbearing potential and male patients with a female partner who is of childbearing potential, contraception and counselling is required.
- Prior PRRT. Patients being considered for re-treatment with PRRT are not eligible
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- Uncontrolled central nervous system metastases. Patients must have completed any surgery or radiation at least 4 weeks prior to registration and must be off corticosteroids for at least 2 weeks
- Any patient, in the opinion of the investigator, who will not comply with study assessments and follow up visits. These might include any social, psychological, or geographical concerns, including alcohol/drug abuse
- Any poorly controlled concurrent medical illness that may prevent the patient from complying with study assessments and follow up. This is to be judged by the treating team
- Any concurrent or prior malignancy that, in the opinion of the treating team, may interfere with study assessments and endpoints
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
Australia9 sites, 9 recruiting
- Recruiting
The Queen Elizabeth Hospital
Adelaide, South Australia, 5000
Prof Timothy Price, 08 8222 6410, Timothy.Price@sa.gov.au
Pam Cooper, 08 8222 6410, pamela.cooper@sa.gov.au
- Recruiting
Royal Brisbane and Womens Hospital
Brisbane, Queensland, 4006
A/Prof Matthew Burge, +61 07 3636 8111, Matthew.Burge@health.qld.gov.au
Poppy Sharman, +61 (07) 3647 0865, Poppy.sharman@health.qld.gov.au
- Recruiting
Cairns Hospital
Cairns, Queensland, 4870
A/Prof Matthew Burge, +61 (07) 4226 0000, Matthew.Burge@health.qld.gov.au
- Recruiting
Kalgoorlie Health Campus
Kalgoorlie-Boulder, Western Australia, 6430
Dr Piyush Grover, +61 (08) 9080 5888, piyush.grover@health.wa.gov.au
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Dr Hui-Li Wong, +61 3 8559 5000, HuiLi.Wong@petermac.org
Naila Pachani, +61 3 8559 5000, naila.pachani@petermac.org
- Recruiting
Fiona Stanley Hospital
Perth, Western Australia, 6150
Dr Piyush Grover, +61 08 6152 6530, piyush.grover@health.wa.gov.au
Anna Cannon, +61 08 6152 6719, anna.cannon@health.wa.gov.au
- Recruiting
Royal North Shore Hospital
Sydney, New South Wales, 2065
Dr David Chan, +61 (02) 8037 4100, david.chan@sydney.edu.au
Cindy (Xiaofang) Han, Xiaofang.Han@health.nsw.gov.au
- Recruiting
Toowoomba Hospital
Toowoomba, Queensland, 4350
A/Prof Matthew Burge, +61 (07) 4616 6000, Matthew.Burge@health.qld.gov.au
- Recruiting
Wollongong Hospital
Wollongong, New South Wales, 2502
Dr Derrick Siu, (02) 4222 5200, howai.siu@health.nsw.gov.au
Victoria Cosatto, (02) 4222 5738, Victoria.Cosatto@health.nsw.gov.au
Canada8 sites, 8 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Dr Stella Koumna, 780-432-8771, koumna@ualberta.ca
Dr Stella Koumna
- Recruiting
London Health Sciences Centre Research Institute (LHSCRI)
London, Ontario, N6A 5W9
Dr David Laidley, 519-685-8500, David.Laidley@lhsc.on.ca
Alisha Moynahan, 519-685-8500, alisha.moynahan@lhsc.on.ca
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 1J8
Dr Rachel Goodwin, 613-737-8899, rgoodwin@toh.ca
Dr Rachel Goodwin
- Recruiting
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Dr Mussawar Iqbal, 306-766-2213, mussawar.iqbal@saskcancer.ca
Dr Mussawar Iqbal
- Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H
Dr Mita Manna, 306-655-2640, mita.manna@saskcancer.ca
Dr Mita Manna
- Recruiting
University Health Network Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Dr Raymond Jang, 416-946-6508, raymond.jang@uhn.ca
Dr Raymond Jang
- Recruiting
Odette Cancer Centre Sunnybrook Health Sciences Centre
Toronto, Ontario, TG 260
Dr Sten Myrehaug, 416-480-4834, sten.myrehaug@sunnybrook.ca
Dr Sten Myrehaug
- Recruiting
BC Cancer Agency, Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Dr Jon Loree, 604-877-6000, jloree@ctg.queensu.ca
Tathiana Ruiz, tathiana.ruiz@bccancer.bc.ca
About this study
Official title: A Randomised Study of Cessation of Somatostatin Analogues After Peptide Receptor Radionuclide Therapy in Mid, Hind-Gut and Pancreatic Neuroendocrine Tumours (STOPNET)
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.
Read the detailed 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
- To estimate the 20-month progression free survival rate after PRRT commencement in patients who cease and who continue SSA.
- Feasibility as measured by:
- Recruitment rate and
- 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.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Cessation of somatostatin analogues, Continuation of somatostatin analogues
- Keywords
- Advanced, Unresectable grade 1 or 2, mid, hind- gut or pancreatic neuroendocrine tumours
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cessation of somatostatin analoguesDrug
Also called SSA cessation
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.
Continuation of somatostatin analoguesDrug
Also called SSA continuation
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.
| Study group | Role | What they receive |
|---|---|---|
| Continue SSA | Active comparator | Patients randomised to continue SSA will receive a SSA injection ≥28 days prior to the first PRRT cycle, during PRRT cycle, and every 4 weeks after completion of PRRT. Receives: Drug: Continuation of somatostatin analogues |
| Cease SSA | Experimental | Patients randomised to cease SSA will receive SSA injection ≥28 days prior to their first cycle of PRRT. Patients will not receive any further long acting SSA injections after this time. Receives: Drug: Cessation of somatostatin analogues |
What is being measured
The primary outcome is the main question the study is designed to answer.
20-month progression free survival rate after PRRT
Estimate the 20-month progression free survival rate after PRRT in patients who cease and who continue SSA.
Measured: 20 months
Assess the barriers which would impede the feasibility of a subsequent phase 3 trial
- Proportion of participants that remained on the SSA cessation arm for the duration of the 20-month study follow up (patient acceptance of SSA cessation).
- Rate of recruitment: ability to complete recruitment over the 24-month recruitment period
Measured: 20 months
Secondary outcomes (9)
Measure Quality of life using the European Organisation For Research And Treatment Of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30) scales
Responses to the QLQ-C30 scale from 0-100 using EORTC guidelines, with higher scores reflecting better level of functioning.
Measured: 20 months
Measure Quality of life using the EORTC QLQ-GINET21 scales
Responses to the QLQ-GINET21 scale from 0-100 using EORTC guidelines, with higher scores reflecting more severe symptoms.
Measured: 20 months
Cost-effectiveness of SSA therapy cessation
Access to Medicare and PBS data to asses use of other healthcare providers, diagnostic tests and imaging services funded via public health care systems and use of pharmaceutical services respectively.
Measured: The MBS/PBS data will be obtained for the period six months prior to study entry, and until the end of 2 years follow-up post PRRT for patients who have provided consent.
Psycho-oncological impacts of SSA therapy cessation: Decision Regret
Psycho-oncological impacts of SSA therapy cessation using the self-reported measures of Decision Regret Scale from 1 - 5 (1-Strongly Agree, 2-Agree, 3-Neither Agree Nor Disagree, 4-Disagree, 5-Strongly Disagree)
Measured: 20 months
Psycho-oncological impacts of SSA therapy cessation: Fear of Cancer Progression
Psycho-oncological impacts of SSA therapy cessation using the self-reported measures of the Fear of Cancer Progression Scale from 1 - 5 (1-Never, 2-Seldom, 3-Sometimes, 4-Often, 5-Very often)
Measured: 20 months
Psycho-oncological impacts of SSA therapy cessation: Decisional Conflict
Psycho-oncological impacts of SSA therapy cessation using the self-reported measures of the Decisional Conflict Scale from 0 - 4 (0-Strongly Agree, 1-Agree, 2-Neither Agree Nor Disagree, 3-Disagree, 4-Strongly Disagree)
Measured: 20 months
Time to commencement of subsequent therapy
Time to commencement of subsequent therapy (e.g re-challenge with PRRT, liver directed therapies, chemotherapy, targeted therapies)
Measured: 20 months
Overall survival
Estimate the 20-month overall survival rate in patients who cease and who continue SSA.
Measured: 20 months
Rates of SSA being recommenced over time
Cumulative percentage of SSA recommencement over time.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start14 Oct 2024
- Primary completionSep 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australasian Gastro-Intestinal Trials Group
- Sponsor type
- Research network
- Collaborators
- Canadian Cancer Trials Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345079
- Sponsor's protocol ID
- AG0219NET
- Acronym
- STOPNET
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study of Cessation of Somatostatin Analogues After Peptide Receptor Radionuclide Therapy in Mid, Hind-Gut and Pancreatic Neuroendocrine Tumours (STOPNET)
- ClinicalTrials.gov ID
- NCT06345079
- Acronym / sponsor ID
- STOPNET / AG0219NET
- Conditions
- Neuroendocrine Tumors
- Keywords
- Advanced, Unresectable grade 1 or 2, mid, hind- gut or pancreatic neuroendocrine tumours
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Australasian Gastro-Intestinal Trials GroupResearch network
- Collaborators
- Canadian Cancer Trials Group
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- To estimate the 20-month progression free survival rate after PRRT commencement in patients who cease and who continue SSA.
- Feasibility as measured by:
- Recruitment rate and
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continue SSA | Active comparator | Drug: Continuation of somatostatin analoguesPatients randomised to continue SSA will receive a SSA injection ≥28 days prior to the first PRRT cycle, during PRRT cycle, and every 4 weeks after completion of PRRT. |
| Cease SSA | Experimental | Drug: Cessation of somatostatin analoguesPatients randomised to cease SSA will receive SSA injection ≥28 days prior to their first cycle of PRRT. Patients will not receive any further long acting SSA injections after this time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Adults over 18 years of age with well or moderately differentiated mid or hindgut neuroendocrine tumour, or pancreatic neuroendocrine tumour, metastatic and inoperable, demonstrating progression despite SSA treatment of sufficient disease magnitude to warrant PRRT as determined by the treating clinician and/or the NET Multidisciplinary Team (MDT).
- Must have measurable disease on triphasic CT/MRI as per RECIST 1.1.
- Ki67 ≤ 20% AND mitotic count 20 per HPF (i.e., WHO grade 1 or 2)
- Patient has been receiving growth-controlling doses of SSA for at least 12 weeks prior to study entry. This is a minimum of 30 mg Octreotide or120mg lanreotide monthly.
- Uptake on SSTR PET scan demonstrating somatostatin receptor expression that is suitable for PRRT as judged by the clinical team. FDG PET scans are to be done at the judgement of the treating team and are not required for enrolment into this study.
Key exclusion criteria (10 listed)
- This study is for pancreatic, mid-gut and hind-gut NET only. Gastric and lung NETs are excluded
- Any patient on an SSA dose lower than the standard growth-control dose. Patients must have been on octreotide 30 mg or lanreotide 120 mg for at least 3 months prior to study entry.
- Prior chemotherapy or targeted therapy (e.g., everolimus). Patients who have received prior local therapy, including external beam radiotherapy and liver directed therapy prior to or during SSA therapy are eligible.
- Any contraindication to PRRT, as per local institutional practice.
- Pregnancy. For female patients of childbearing potential and male patients with a female partner who is of childbearing potential, contraception and counselling is required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cessation of somatostatin analoguesAlso: SSA cessationPatients 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 | Cease SSA |
| Continuation of somatostatin analoguesAlso: SSA continuationPatients 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. | Drug | Continue SSA |
Primary outcome
20-month progression free survival rate after PRRT
Time frame: 20 months
Estimate the 20-month progression free survival rate after PRRT in patients who cease and who continue SSA.
Assess the barriers which would impede the feasibility of a subsequent phase 3 trial
Time frame: 20 months
1. Proportion of participants that remained on the SSA cessation arm for the duration of the 20-month study follow up (patient acceptance of SSA cessation). 2. Rate of recruitment: ability to complete recruitment over the 24-month recruitment period
9 secondary outcomes
Measure Quality of life using the European Organisation For Research And Treatment Of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30) scales
Time frame: 20 months
Measure Quality of life using the EORTC QLQ-GINET21 scales
Time frame: 20 months
Cost-effectiveness of SSA therapy cessation
Time frame: The MBS/PBS data will be obtained for the period six months prior to study entry, and until the end of 2 years follow-up post PRRT for patients who have provided consent.
Psycho-oncological impacts of SSA therapy cessation: Decision Regret
Time frame: 20 months
Psycho-oncological impacts of SSA therapy cessation: Fear of Cancer Progression
Time frame: 20 months
Psycho-oncological impacts of SSA therapy cessation: Decisional Conflict
Time frame: 20 months
Time to commencement of subsequent therapy
Time frame: 20 months
Overall survival
Time frame: 20 months
Rates of SSA being recommenced over time
Time frame: 20 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cessation of somatostatin analogues and Continuation of somatostatin analogues in people with Neuroendocrine Tumors, run by Australasian Gastro-Intestinal Trials Group at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Kuszewski (+61 02 7208 2725, gct_stopnet_mailbox@gicancer.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20-month progression free survival rate after PRRT (time frame: 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.