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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

The investigators will include all patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2021.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Histopathological review

    Other intervention

    Histopathological review

Treatment groups

3,200 Participants
are divided into 1 treatment group
Group A: Histopathological review1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the 10-year overall survival of non-curative metastatic siNET with or without primary tumor resection at initial diagnosis in asymptomatic patients.

For the survival analysis, Kaplan-Meier method will be used to estimate overall survival at 10 years for patients with and without primary tumor resection.

Time frame
10 years follow-up

Secondary outcomes

1

To evaluate the progression-free survival of non-curative metastatic siNET with or without primary tumor resection at initial diagnosis in asymptomatic patients.

For the survival analysis, Kaplan-Meier method will be used to estimate overall survival at 10 years for patients with and without primary tumor resection.

Time frame
10 years follow-up
2

To examine the risk of small intestinal obstruction with or without palliative primary tumor resection

To account for additional established prognostic information, univariable and multivariable Cox proportional hazards regression will be used.

Time frame
10 years follow-up
3

To examine the risk of small intestinal hypoperfusion with or without palliative primary tumor resection

To account for additional established prognostic information, univariable and multivariable Cox proportional hazards regression will be used.

Time frame
10 years follow-up
4

To evaluate the morbidity of palliative primary tumor resection

To account for additional established prognostic information, univariable and multivariable Cox proportional hazards regression will be used.

Time frame
10 years follow-up

Other outcomes

Sponsors and contacts

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