Continuing somatostatin analogues for patients with advanced neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of continuing somatostatin analogues in patients with advanced gastroenteropancreatic neuroendocrine tumors who show disease progression after initial treatment. Participants will be randomly assigned to either continue or stop somatostatin analogue therapy when starting second-line treatment, which may include peptide receptor radionuclide therapy or targeted therapy. The study aims to determine the impact of this decision on patient outcomes, with stratification based on tumor characteristics and treatment site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Written informed consent prior to any study-related procedures
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2,
* Histologically-proven diagnosis of locally advanced or metastatic, non-functional, well-differentiated World Health Organisation 2019 grade 1-2 GEP NET
* Documented radiological disease progression on first-line SSA treatment at label dose or higher
* For targeted therapy substudy: indication to start with either sunitinib or everolimus as second-line therapy, according to local investigator
* For PRRT substudy: indication to start with PRRT with Lutetium (177Lu) oxodotreotide as second-line therapy, according to local investigator

Exclusion Criteria:

* Indication for chemotherapy treatment of GEP NET in second-line
* Presence of poorly differentiated grade 3 neuroendocrine carcinoma (NEC), well-differentiated grade 3 NET or rapidly progressive NET
* Prior treatment with everolimus, sunitinib or PRRT
* Contra-indication, proven allergy or other indication than functional NET for the use of a SSA
* Patient showing progressive disease while being on a lower than the registered dose
* Functional NET, defined as the presence of clinical and biochemical evidence of a hormonal NET-related syndrome
* Patient undergoing palliative, systemic oncological treatment for other malignancy than GEP NET
* Concurrent anti-cancer treatment in another investigational trial
* Any abnormal findings at screening, clinical finding, including psychiatric and behavioural problems, or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study
* Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial

Where it's running

• AZ Klina
  Brasschaat, Antwerp, Belgium Recruiting
• Vitaz
  Sint-Niklaas, East-Flanders, Belgium Recruiting
• University Hospital Leuven
  Leuven, Flemish Brabant, Belgium Recruiting
• Cliniques Universitaires Saint-Luc
  Brussels, Belgium Recruiting
• Antwerp University Hospital
  Edegem, Belgium Recruiting
• Rijnstate
  Arnhem, Gelderland, Netherlands Recruiting

Study contacts

• Principal investigator: Marc Peeters, MD — University Hospital, Antwerp
• Study coordinator: Marc U Peeters, MD
• Email: sauna@uza.be
• Phone: 03821

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GEP-NET treatment patterns and outcomes in the U.S.

  This study will see how newly diagnosed GEP-NET patients are treated in real-world settings and what their outcomes look like.

  Recruiting Novartis · East Hanover, New Jersey · NCT07635316

• Nutritional status monitoring for adults with gastroenteropancreatic neuroendocrine tumors

  This project will see if nutrition problems are common and linked to outcomes in adults aged 18–70 being followed for gastroenteropancreatic neuroendocrine tumors at Strasbourg University Hospital.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07302100

• RYZ401 for solid tumors that express somatostatin receptors

  This trial will try RYZ401, a targeted radiotherapy, in adults with neuroendocrine or other solid tumors that show somatostatin receptors to find a safe dose and see if it shrinks tumors.

  Recruiting at 15 sites Phase 1 RayzeBio, Inc. · Phoenix, Arizona and 14 other locations · NCT07165132

• Characterizing Gastroenteropancreatic Neuroendocrine Tumors Treated With Targeted Radionuclide Therapy

  This study is trying to see if advanced imaging can help doctors choose the right patients for a specific cancer treatment for gastroenteropancreatic neuroendocrine tumors to improve their chances of success.

  Recruiting at 3 sites Assistance Publique - Hôpitaux de Paris · Clichy and 4 other locations · NCT06256705

• Using 68Ga-DOTATOC PET to evaluate gastroenteropancreatic neuroendocrine tumors

  This study is testing if a special type of PET scan can help doctors better diagnose gastroenteropancreatic neuroendocrine tumors in adults.

  Recruiting IRCCS San Raffaele · Milan · NCT06155318

• Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

  This study is testing a new type of treatment using targeted alpha-particle therapy to see if it can help people with advanced neuroendocrine tumors that have a specific protein called SSTR2.

  Recruiting at 20 sites Phase 1/2 Perspective Therapeutics · Jacksonville, Florida and 19 other locations · NCT05636618

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.