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Recruiting NCT07314164

Study of Cabozantinib in Participants With Neuroendocrine Tumors Who Have Already Received Prior Treatment

— Observational Neuroendocrine Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Neuroendocrine Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

CaboLife: A Prospective Non-Interventional Study on Effectiveness and Safety of Cabozantinib in Real-Life Setting for Previously Treated Patients With Neuroendocrine Tumour

Overview

This study will assess how well cabozantinib works and how safe it is in adults with a type of cancer called neuroendocrine tumors (NETs). These tumors can appear in all parts of the body. All participants in this study have already received at least one treatment that affects the whole body to help manage their cancer, but their disease has continued to grow. The study will take place in regular hospitals and clinics in Germany and Austria. It will follow about 150 participants who are taking cabozantinib as part of their usual care. Doctors will collect information from routine medical visits, tests, and scans to see how the cancer responds to treatment and how long participants stay on cabozantinib. They will also look at side effects and how the treatment affects participants' quality of life. This is an observational study, which means that no extra tests or procedures will be done beyond what is normally used to care for participants with this condition.

Primary outcome measures

  • Disease Control Rate (DCR) [Time frame: At 6 Months]
Secondary outcome measures (12)
  • Objective Response Rate (ORR) [Time frame: Up to 18 Months]
  • Change from baseline in global and subscale scores of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) [Time frame: Baseline and Every 3 Months up to 18 Months]
  • Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Gastrointestinal Neuroendocrine Tumors Module (EORTC QLQ-GINET21) [Time frame: Baseline and Every 3 Months up to 18 Months]
  • Percentage of participants experiencing Adverse Events (AEs), non-serious, drug-related, or serious Adverse Events (SAEs) [Time frame: Up to 18 Months]
  • Percentage of participants with any dose modification due to AEs. [Time frame: Up to 18 months]
  • Duration of treatment (DoT) [Time frame: Up to 18 Months]
  • Percentage of participants switching to a new line of therapy [Time frame: Up to 18 Months]
  • Disease control rate after switch to next line of therapy [Time frame: 3 Months After Therapy Switch]
  • Chromogranin A Levels [Time frame: Baseline and Every 3 Months up to 18 Months]
  • Neuron-Specific Enolase blood levels. [Time frame: Baseline and Every 3 Months up to 18 Months]
  • Time to next treatment [Time frame: Up to 18 Months]
  • Progression-Free Survival (PFS) [Time frame: Up to 18 Months]

Eligibility criteria

Inclusion criteria

Participants can join the study if they meet all of the following conditions:

  • Are 18 years or older and able to give informed consent.
  • Have a physician-initiated decision to start treatment with cabozantinib for neuroendocrine tumors (NETs), made before joining the study.
  • Have unresectable or metastatic, well-differentiated pancreatic (pNET) or extra-pancreatic neuroendocrine tumors (epNET).
  • Have already received at least one prior systemic therapy, other than somatostatin analogues.
  • Have signed a written informed consent form.

Exclusion criteria

Participants cannot join the study if:

  • They are currently participating in an interventional clinical trial, or have done so within the last 3 months before joining this study.
  • They have a contraindication to cabozantinib treatment, based on the product's official prescribing information.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 31 centers
  • MVZ am Klinikum Aschaffenburg — Aschaffenburg
  • Charité - Universitaetsmedizin Berlin — Berlin
  • DRK Kliniken Berlin — Berlin
  • Evangelische Lungenklinik Berlin — Berlin
  • Krankenhaus St. Joseph-Stift Bremen GmbH — Bremen
  • Klinikum Chemnitz — Chemnitz
  • MVZ fuer Haematologie und Onkologie Koeln am Sachsenring — Cologne
  • pioh Studien und Mangement GbR — Cologne
  • … and 23 more centers
Austria · 3 centers
  • Medizinische Universitaet Graz — Graz
  • Kepler Universitaetsklinikum GmbH Linz — Linz
  • Medizinische Universität Wien — Vienna

Identifiers

NCT: NCT07314164 · CLIN-60000-467

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗