Actively Recruiting

All Genders
NCT06787014

Resection of the Primary Tumor vs. Systemic Treatment Alone for Patients With Small Intestinal Neuroendocrine Tumors and Unresectable Metastases: a Europe-wide Study

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-03-18

3200

Participants Needed

1

Research Sites

146 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Resection of the Primary Tumor vs. Systemic Treatment Alone for Patients With Small Intestinal Neuroendocrine Tumors and Unresectable Metastases: a Europe-wide Study

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with small intestinal neuroendocrine tumors (siNET) and non-curative metastatic disease diagnosed between January 1, 2005, and December 31, 2021
Not Eligible

You will not qualify if you...

  • Patients with siNET grade 3 tumors
  • Patients with resectable metastatic disease
  • Patients with non-resectable primary tumor at initial diagnosis
  • Patients who have symptoms like small intestinal obstruction or bleeding at diagnosis
  • Patients with imaging signs suggesting probable obstruction (bowel dilatation or mesenteric fibrosis) at diagnosis
  • Patients who have refused further use of their data for scientific research

AI-Screening

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Trial Site Locations

Total: 1 location

1

UHI Berne

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

E

Eliane Dohner

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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