Somatostatin analogues after PRRT for nonfunctional 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 is a multicenter, randomized, open-label phase III trial. It compares standard-of-care somatostatin analogue therapy to observation in patients who have completed PRRT with ethanol-stabilized Lu-177 dotatate for metastatic, unresectable gastroentero-pancreatic neuroendocrine tumors. Eligible participants have well- to moderately-differentiated GI-NETs, measurable disease, and are suitable for SSA treatment. Randomization may occur before or during PRRT depending on enrollment timing. The trial aims to determine if continued SSA therapy after PRRT improves outcomes versus observation alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed metastatic, unresectable, well- or moderately-differentiated, nonfunctional gastrointestinal neuroendocrine tumor (GI-NETs). This includes pancreatic neuroendocrine neoplasms. Any grade (grade 1, grade 2, or grade 3) is permitted.
* Measurable disease per RECIST 1.1.
* Appropriate for ethanol-stabilized Lu-177 dotatate treatment, as determined by positive screening with SSTR PET/CT and/or currently having received up to 3 fractions of PRRT. (Patients will be randomized prior to the start of PRRT or during PRRT, depending on the timing of enrollment.)
* Eligible for somatostatin analogue treatment per the treating physician.
* At least 18 years of age.
* ECOG performance status ≤ 2 or Karnofsky ≥ 60%
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression, as determined by a repeat imaging study at least 4 weeks following the completion of treatment. Patients with treated brain metastases must also be off steroids for at least 1 month and stable.
* The effects of ethanol-stabilized Lu-177 dotatate and SSAs on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radionucleotides and anti-angiogenic agents are known to be teratogenic, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months following last administration of PRRT for males and 7 months after last administration of PRRT for females, or 4 months after last day of SSA, whichever is later.
* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion Criteria:

* Completed prior treatment with PRRT for non-GI-NET diagnosis (i.e. in need of salvage PRRT treatment).
* Major surgery within 4 weeks from randomization to the trial.
* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
* Currently receiving any investigational agents.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to SSAs.
* Evidence of hypersensitivity to ethanol containing compounds.
* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 15 days of study entry.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• University of California - San Francisco
  San Francisco, California, United States Not yet recruiting

Study contacts

• Principal investigator: Nikolaos Trikalinos, MD, MS — Washington University School of Medicine
• Study coordinator: Nikolaos Trikalinos, MD, MS
• Email: ntrikalinos@wustl.edu
• Phone: 314-273-4959

Similar studies

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

• CTX-471 for NCAM-positive metastatic neuroendocrine tumors

  A phase 2 trial is testing CTX-471 in adults with NCAM (CD56) positive metastatic neuroendocrine tumors that have progressed after standard therapy.

  Recruiting at 2 sites Phase 2 Compass Therapeutics · St Louis, Missouri and 1 other locations · NCT07684170

• Investigating the impact of somatostatin analogues on tumor dose during radionuclide therapy

  This study is testing if stopping or continuing long-acting somatostatin treatment affects how well radionuclide therapy works for adults with neuroendocrine tumors.

  Recruiting Phase 2/3 The Netherlands Cancer Institute · Amsterdam · NCT06855095

• Assessing the safety and efficacy of a new treatment for neuroendocrine tumors

  This study is testing a new treatment for patients with advanced neuroendocrine tumors to see if it is safe and effective.

  Recruiting Phase 1 Peking University Cancer Hospital & Institute · Beijing, Beijing Municipality · NCT06732505

• Understanding genetic causes of neuroendocrine tumors in Mexican patients

  This study is trying to find out the genetic changes that cause neuroendocrine tumors in Mexican patients to help develop better treatments.

  Recruiting at 3 sites Universidad Nacional Autonoma de Mexico · Mexico City, Mexico City and 2 other locations · NCT06523582

• Young adults with gastrointestinal and neuroendocrine cancers

  This study is trying to gather samples from young adults with gastrointestinal and neuroendocrine cancers to learn more about their specific needs and improve treatment options for them.

  Recruiting European Institute of Oncology · Milan · NCT06337760

• Combination therapy for advanced high-grade neuroendocrine neoplasms

  This study is testing a new combination of three treatments to see if they can help people with advanced high-grade neuroendocrine tumors who haven't had success with standard therapies.

  Recruiting at 2 sites Phase 2 Peking University · Beijing, Beijing Municipality and 1 other locations · NCT05165407

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.