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NCT07890012

Real World Positioning of Tyrosine Kinase Inhibitors (TKIs) Within Systemic Treatment Strategies for Advanced Neuroendocrine Tumors (NETs)

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

Well differentiated neuroendocrine tumors (NETs) are rare and heterogeneous malignancies that frequently evolve toward advanced or metastatic disease, requiring long-term systemic treatment strategies delivered over multiple lines. Their management is complex and influenced by tumor-related factors-including primary site and grade-as well as disease burden, functional status, patient comorbidities, and access to available therapeutic options. As a result, real-world treatment pathways in advanced NETs are highly diverse. In recent years, the systemic treatment landscape of advanced NETs has expanded beyond somatostatin analogues (SSA), peptide receptor radionuclide therapy (PRRT), and chemotherapy to include targeted therapies. Among these, multitarget tyrosine kinase inhibitors (TKIs) targeting tumor angiogenesis have progressively been incorporated into clinical practice. Their use varies according to tumor subtype, disease dynamics, prior treatments, and patient-related considerations, reflecting the absence of standardized sequencing algorithms. In routine clinical practice, the choice and sequencing of TKIs are driven by individualized clinical decision-making rather than predefined treatment pathways. Their positioning within systemic treatment strategies is influenced by anticipated benefit, tolerability, prior toxicities, and practical constraints such as regulatory indications, access, and reimbursement conditions, which differ by tumor origin. Consequently, the real-world positioning of TKIs within treatment sequences remains insufficiently characterized at a national level. "SEQUENCE-NET" is an ambispective observational study designed to prospectively document how TKIs are integrated into systemic treatment strategies for advanced pancreatic and extra-pancreatic NETs in routine clinical practice within the ENDOCAN-RENATEN network.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2027-01-01

Completion Date

2028-07-01

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

OTHER

PRO-CSS questionnaire

PRO-CSS is a validated patient-reported questionnaire designed to assess the severity of carcinoid syndrome symptoms and their impact on daily life. It evaluates symptoms such as diarrhoea, flushing, urgency, abdominal pain, and fatigue, as well as their effects on daily activities, diet, travel, and overall quality of life. The questionnaire provides a standardized assessment of symptom burden from the patient's perspective and may help monitor symptom control over time. The questionnaire must be completed at baseline, than at 1, 2 and 3 months after TKI's treatment started.

Locations (18)

CHU Angers

Angers, France

CHU de Caen

Caen, France

Hôpital Beaujon APHP

Clichy, France

CHU Dijon Bourgogne

Dijon, France

CHU Grenoble-Alpes

La Tronche, France

CHRU de Lille - Hôpital Claude Huriez

Lille, France

Hôpital Edouard Herriot

Lyon, France

CHU Nantes

Nantes, France

Institut Curie

Paris, France

Hôpital Saint Antoine APHP

Paris, France

Hôpital Cochin APHP

Paris, France

Hôpital Européen Georges Pompidou

Paris, France

CHU Bordeaux- Hôpital Haut-Lévêque

Pessac, France

CHU Poitiers

Poitiers, France

CHU Reims - Hôpital Robert Debré

Reims, France

CHRU Strasbourg - Hôpital de Hautepierre

Strasbourg, France

CHU Tours - Hôpital Trousseau

Tours, France

Institut Gustave Roussy

Villejuif, France