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Идёт набор NCT07273409

Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not

Без фазы С лечением Pancreatic Neuroendocrine Tumor

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
В протоколе указаны: Debulking surgery.
Кому может быть актуально
Состояния в реестре: Pancreatic Neuroendocrine Tumor. 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
Швеция
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

PANcreatic Neuroendocrine Tumour - Optimal Surgical Debulking Or Not (PANTODON). A Prospective, Two Armed, Parallel, Randomised, Controlled International Multicentre Study on WHO Grade 1-2, Stage 4 Pancreatic NET

Обзор

Pancreatic neuroendocrine tumours (pan-NETs) are neoplasms arising from the endocrine cells of the pancreas. Although pan-NET are quite rare, the incidence is on the rise and together with other abdominal neuroendocrine tumours an approximate incidence in Sweden would be 850 patients per year extrapolating from Norwegian data. Pan-NET are divided into symptomatic hormone producing tumours (such as insulinomas/glucagonomas/VIPomas) or non-functioning tumours that often are asymptomatic. As early symptoms often are lacking in non-functioning-pan-NET, many patients present with distant metastases and are thus beyond a curative surgical approach at the time of diagnosis. Metastatic non-functioning pan-NETs present a significant challenge and the optimal management remains a subject of debate. This is a prospective, two armed, parallel, randomised, controlled, international multi-centre study, aiming to investigate if a near-total tumour debulking (intervention) in metastatic (stage 4) GI-WHO grade 1-2 pan- NET, with or without oncologic treatment, is superior to oncologic treatment alone (control), with regards to overall survival, health-related quality of life, participant performance status, time until hospitalisation, adverse event characteristics and cost in the short and long term.

Вмешательства

  • Процедура Debulking surgery
    All subjects are divided into STRATUM 1 and STRATUM 2 prior to randomisation. For subjects in STRATUM 1, the surgical resection, alone or in combination with ablative procedures, aim to achieve at least 70% debulking of the total tumour volume, with acceptable risk and acceptable functional liver remnant (FLR). For subjects in STRATUM 2 the aim is to resect or ablate all FluDeoxyGlucose-Positron emission tomography (FDG-PET) avid disease with acceptable risk and acceptable FLR.

Первичные конечные точки

  • Overall survival [Срок оценки: Five years or until death.]
Вторичные конечные точки (6)
  • Health economics [Срок оценки: Until end of trial.]
  • Health-related quality of life [Срок оценки: The questionnaire will be filled in by the study subject before randomisation, at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.]
  • Performance status [Срок оценки: Assessed at screening, at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.]
  • Days out of hospital [Срок оценки: Assessed at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.]
  • Days out of intensive care unit [Срок оценки: Assessed at 1 and 5 years.]
  • Adverse events [Срок оценки: From randomisation until the end of the study period.]

Критерии участия

Критерии включения

  • Pan- NET, ENETS/AJCC stage 4 determined by CT or PET/CT
  • Primary tumour or metastases confirmed as Pancreatic NET GI-WHO grade 1-2 pan-NET by histology or cytology
  • Age ≥ 18 years
  • Written informed consent obtained

Критерии исключения

  • Subject not fit for surgery due to comorbidity or advanced age (reason to be specified)
  • Risk of surgery deemed too high by MDT or Surgeon (reason to be specified)
  • Previous surgery for pan-NET.
  • Hormonal symptoms caused by a functional pan-NET, not controllable by medical therapy, indicating debulking surgery.
  • Previously included in the current study.
  • Pregnancy
  • The study subject does not fit into either STRATA: a) STRATUM 1: Less than 70% of the total tumour volume can be debulked, b) STRATUM 2: no FDG-PET avid disease is observed OR all (100%) FDG-PET avid tumour is not resectable.
  • Other reason in the opinion of the Principal Investigator (reason to be specified).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Швеция · 4 центра
  • Sahlgrenska University Hospital — Gothenburg
  • Skåne University Hospital — Lund
  • Karolinska University Hospital — Stockholm
  • Uppsala University Hospital — Uppsala

Идентификаторы

NCT: NCT07273409 · PANTODON/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗