Neuroendocrine Tumors
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | At 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 18 Months | Proportion of participants who achieve complete or partial response based on radiographic assessments. |
| 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) | Baseline and Every 3 Months up to 18 Months | 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). |
| Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Gastrointestinal Neuroendocrine Tumors Module (EORTC QLQ-GINET21) | Baseline and Every 3 Months up to 18 Months | 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). |
| Percentage of participants experiencing Adverse Events (AEs), non-serious, drug-related, or serious Adverse Events (SAEs) | Up to 18 Months | 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. |
| Percentage of participants with any dose modification due to AEs. | Up to 18 months | Percentage of participants who experienced at least one dose reduction, interruption, or discontinuation due to adverse events during the study period. |
| Duration of treatment (DoT) | Up to 18 Months | Time from first dose to last dose of cabozantinib. |
| Percentage of participants switching to a new line of therapy | Up to 18 Months | Percentage of participants who initiated a new line of therapy during the study period. The type of therapy received after switch will be reported descriptively and is not considered a formal outcome measure. |
| Disease control rate after switch to next line of therapy | 3 Months After Therapy Switch | Proportion of participants achieving complete response, partial response, or stable disease within 3 months after switching to a new therapy, based on radiographic assessment performed as part of routine care. |
| Chromogranin A Levels | Baseline and Every 3 Months up to 18 Months | Chromogranin A blood levels measured during routine care. |
| Neuron-Specific Enolase blood levels. | Baseline and Every 3 Months up to 18 Months | Neuron-Specific Enolase blood levels measured during routine care. |
| Time to next treatment | Up to 18 Months | Time from first dose of cabozantinib to initiation of subsequent therapy. |
| Progression-Free Survival (PFS) | Up to 18 Months | Time from first dose of cabozantinib to disease progression or death from any cause. |
| Progression-Free Survival Rate at 12 and 18 Months | At 12 and 18 Months | Number of participants without disease progression or death. |
Countries
Austria, Germany
Contacts
CONTACTIpsen Clinical Study Enquiries
STUDY_DIRECTORIpsen Medical Director
Ipsen
Outcome results
None listed