Study of Cabozantinib in Participants With Neuroendocrine Tumors Who Have Already Received Prior Treatment
ConditionNeuroendocrine Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIpsen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
150 adult participants in Austria and Germany who are prescribed cabozantinib tablets for unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues prior to entry into the study will be included.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Disease Control Rate (DCR)
Proportion of participants who achieve complete response, partial response, or stable disease within 6 months of cabozantinib treatment, based on radiographic assessments performed as part of routine care.
Time frame
At 6 MonthsSecondary outcomes
1
Objective Response Rate (ORR)
Proportion of participants who achieve complete or partial response based on radiographic assessments.
Time frame
Up to 18 Months2
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)
A validated 30-item questionnaire designed to assess the general health-related quality of life of cancer patients. It includes: 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain) a global health status/QoL scale and several single items (e.g., dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
Time frame
Baseline and Every 3 Months up to 18 Months3
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Gastrointestinal Neuroendocrine Tumors Module (EORTC QLQ-GINET21)
A 21-item module developed to supplement the QLQ-C30 for patients with gastrointestinal neuroendocrine tumors (GI-NETs). It includes 5 scales (Endocrine symptoms, Gastrointestinal symptoms, Treatment-related side effects, Social functioning, Disease-related worries) and 5 single items (weight loss, weight gain, muscle and/or bone pain, information, sexual functioning).
Time frame
Baseline and Every 3 Months up to 18 Months4
Percentage of participants experiencing Adverse Events (AEs), non-serious, drug-related, or serious Adverse Events (SAEs)
An Adverse event (AE) is any untoward medical occurrence, temporally associated with the use of study intervention, whether or not related to the study intervention.
Time frame
Up to 18 Months Source ClinicalTrials.gov