Clinical trial for Neuroendocrine Tumors
Official title Cessation of Somatostatin Analogues After PRRT in Mid, Hind-Gut and Pancreatic Neuroendocrine Tumours
ClinicalTrials.gov ID: NCT06345079
What this study is testing
What is Cessation of somatostatin analogues?
Cessation of somatostatin analogues is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for neuroendocrine tumors.
Also referred to as SSA cessation.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether stopping somatostatin analogues after PRRT is safe and how well it works for people with grade 1 or 2 mid‑gut, hind‑gut, or pancreatic neuroendocrine tumors.
- Who it's for
- You may be able to join if you have a grade 1 or 2 well‑differentiated mid‑gut, hind‑gut or pancreatic neuroendocrine tumor that has grown while on somatostatin analogues.
- What's involved
- You will receive PRRT treatment. Some people will keep taking the somatostatin analogue, others will stop it. You will have check‑ups and scans to see how the tumor behaves.
- Time commitment
- The study lasts for several months, with visits for PRRT and follow‑up scans after treatment.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults over 18 years of age with well or moderately differentiated mid or hindgut neuroendocrine tumour, or pancreatic neuroendocrine tumour
- 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).
- Note: Participants are eligible if only a single proliferation index has been performed due to local institutional practice, provided that the...
- Never had escalation of the SSA treatment dose to control carcinoid or other hormone-related symptoms.
You likely can't join if
- 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.
- Prior chemotherapy or targeted therapy (e.g., everolimus). Patients who have received prior local therapy, including external beam radiotherapy and...
- 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...
- Prior PRRT. Patients being considered for re-treatment with PRRT are not eligible.
See the full eligibility criteria
- Adults over 18 years of age with well or moderately differentiated mid or hindgut neuroendocrine tumour, or pancreatic neuroendocrine tumour
- 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).
- Note: Participants are eligible if only a single proliferation index has been performed due to local institutional practice, provided that the results are consistent with WHO grade 1 or 2 NET.
- Never had escalation of the SSA treatment dose to control carcinoid or other hormone-related symptoms.
- Never required short acting SSA treatment to control carcinoid or other hormone-related symptoms.
- 24-hour urine 5-hydroxyindoleacetic acid (5HIAA) \<3x upper limit of normal.
- No significant carcinoid induced valvular heart disease. I.e. Echocardiogram to be within 12 weeks of study randomisation, and deemed safe to proceed with PRRT by the treating team.
- Note: routine measurement of gastrin, insulin, C-peptide levels, glucagon etc. is not required unless clinically indicated.
- Patient has been receiving growth-controlling doses of SSA for at least 12 weeks prior to study enrolment, for example a minimum of 30mg Octreotide or 120mg Lanreotide monthly.
- Uptake on SSTR PET scan demonstrating somatostatin receptor expression that is suitable for PRRT as judged by the clinical team.
- PRRT is deemed the most appropriate next treatment step (i.e., patient is inoperable, and liver directed therapies are not preferred).
- 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 assigned by chance 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.
- 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 an SSA equivalent to Octreotide 30mg or Lanreotide 120mg for at least 3 months prior to study enrolment.
- 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.
- Uncontrolled central nervous system metastases. Patients must have completed any surgery or radiation at least 4 weeks prior to enrolment 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Sydney, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Brisbane, Queensland, Australia
- Cairns, Queensland, Australia
- Toowoomba, Queensland, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Kalgoorlie-Boulder, Western Australia, Australia
- Perth, Western Australia, Australia
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Regina, Saskatchewan, Canada
- Saskatoon, Saskatchewan, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sydney, New South Wales, Australia; Wollongong, New South Wales, Australia; Brisbane, Queensland, Australia; Cairns, Queensland, Australia; Toowoomba, Queensland, Australia; Adelaide, South Australia, Australia and 10 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.