Идёт набор NCT07314164

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

— Наблюдательное Neuroendocrine Tumors

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Neuroendocrine Tumors. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австрия, Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Первичные конечные точки

Disease Control Rate (DCR) [Срок оценки: At 6 Months]

Вторичные конечные точки (12)

Objective Response Rate (ORR) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Up to 18 Months]
Percentage of participants with any dose modification due to AEs. [Срок оценки: Up to 18 months]
Duration of treatment (DoT) [Срок оценки: Up to 18 Months]
Percentage of participants switching to a new line of therapy [Срок оценки: Up to 18 Months]
Disease control rate after switch to next line of therapy [Срок оценки: 3 Months After Therapy Switch]
Chromogranin A Levels [Срок оценки: Baseline and Every 3 Months up to 18 Months]
Neuron-Specific Enolase blood levels. [Срок оценки: Baseline and Every 3 Months up to 18 Months]
Time to next treatment [Срок оценки: Up to 18 Months]
Progression-Free Survival (PFS) [Срок оценки: Up to 18 Months]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет