NCT06787014 Resection of the Primary Tumor vs. Systemic Treatment Alone for Patients With Small Intestinal Neuroendocrine Tumors and Unresectable Metastases: a Europe-wide Study
| NCT ID | NCT06787014 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Neuroendocrine (NE) Tumors |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,200 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2026-03-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,200 participants in total. It began in 2026-03-09 with a primary completion date of 2026-03-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
When possible, surgery to completely remove small intestinal neuroendocrine tumors (siNETs) is always recommended. However, in cases where the tumor has spread and cannot be cured completely, it is unclear whether a surgical removal of the primary tumor only is reasonable. In this situation, current guidelines from the European Neuroendocrine Tumor Society (ENETS) recommend surgery only for patients who have symptoms like intestinal blockage or bleeding, or are at risk of such complications. For patients without symptoms, it is still unclear whether removing the main tumor improves overall outcomes and prevents future problems. Studies evaluating this type of surgery on survival show conflicting results. These studies often do not separate patients with symptoms from those without, and they overlook other important factors like the amount of cancer in the liver and nearby tissues. Due to these uncertainties, the rarity of siNETs and many factors that can affect outcomes, like age, overall health, or other current treatments, conducting a high-quality study to answer this question is challenging. To address this, the present Europe-wide study is being planned. This study aims to determine if resecting the main tumor improves the 10-year overall survival and reduces risks like intestinal blockages or blood flow issues compared to no surgery in patients without symptoms. The study will also assess other outcomes, such as how long patients stay free from disease progression, the risks of surgery, and prognostic factors for long-term survival. This international collaboration among neuroendocrine tumor referral centers will provide robust evidence to guide clinical practice and update treatment guidelines for siNETs.
Eligibility Criteria
Inclusion Criteria: \- All patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2021 will be included. Exclusion Criteria: \- All patients with siNET G3, resectable metastatic disease and/or non-resectable primary tumor at initial diagnosis will be excluded. Furthermore, symptomatic patients (small intestinal obstruction, bleeding) or when imaging suggests that obstruction will probably occur (bowel dilatation, mesenteric fibrosis) at initial diagnosis will be excluded. Patients with diarrhea, flushing, or abdominal pain will not be excluded. Patients with a documented rejection for a further use of their data for scientific purposes will also be excluded.
Contact & Investigator
Reto M. Kaderli
PRINCIPAL INVESTIGATOR
Insel Gruppe AG, University Hospital Bern
Frequently Asked Questions
Who can join the NCT06787014 clinical trial?
This trial is open to participants of all sexes, studying Neuroendocrine (NE) Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06787014 currently recruiting?
Yes, NCT06787014 is actively recruiting participants. Contact the research team at eliane.dohner@insel.ch for enrollment information.
Where is the NCT06787014 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06787014 clinical trial?
NCT06787014 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Reto M. Kaderli at Insel Gruppe AG, University Hospital Bern. The trial plans to enroll 3,200 participants.