Clinical trial NCT06787014: Resection of the Primary Tumor vs. Systemic Treatment Alone for Patients With Small Intestinal Neuroendocrine Tumors and Unresectable Metastases: a Europe-wide Study
Official title: Resection of the Primary Tumor vs. Systemic Treatment Alone for Patients With Small Intestinal Neuroendocrine Tumors and Unresectable Metastases: a Retrospective, Europe-wide, Pooled Cohort Study (ENETS-SurgSmInt)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neuroendocrine (NE) Tumors
Metastasis
Bowel Obstruction
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 3200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will include all patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2019.

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 31.12.2019 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.

Primary outcomes:
measure: To evaluate the 10-year overall survival of non-curative metastatic siNET with or without primary tumor resection at initial diagnosis in asymptomatic patients.
timeFrame: 10 years follow-up
Secondary outcomes:
measure: To evaluate the progression-free survival of non-curative metastatic siNET with or without primary tumor resection at initial diagnosis in asymptomatic patients.
timeFrame: 10 years follow-up
measure: To examine the risk of small intestinal obstruction with or without palliative primary tumor resection
timeFrame: 10 years follow-up
measure: To examine the risk of small intestinal hypoperfusion with or without palliative primary tumor resection
timeFrame: 10 years follow-up
measure: To evaluate the morbidity of palliative primary tumor resection
timeFrame: 10 years follow-up
measure: To evaluate the mortality of palliative primary tumor resection
timeFrame: 10 years follow-up
measure: To assess prognostic factors for long-term survival
timeFrame: 10 years follow-up
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: UHI Berne
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Reto Kaderli
role: PRINCIPAL_INVESTIGATOR
References: