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Идёт набор NCT06057350

Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

Без фазы С лечением Treatment Side Effects Colorectal Cancer

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: Tumor removal.
Кому может быть актуально
Состояния в реестре: Treatment Side Effects, Colorectal Cancer. Базовые параметры: от 40 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
Норвегия, Польша
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

Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial

Обзор

Randomized head-to-head comparison trial among patients who have undergone incomplete endoscopic resection of early colon cancer to evaluate the benefits, harms and burdens, as well as the ecological footprint and cost-effectiveness of endoscopic full thickness resection (eFTR), a minimally invasive endoscopic treatment with a colonoscope, as compared to standard-of-care surgery. Co-primary endpoints are * Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment * CRC recurrence or sign of lymph nodes or distant metastases at 3 years after randomization comparing the two treatment groups (eFTR versus surgery).

Вмешательства

  • Процедура Tumor removal
    Removal of incompletely removed early-stage colon cancer

Первичные конечные точки

  • Severe adverse events [Срок оценки: 30 days]
  • CRC recurrence or sign of lymph nodes or distant metastases [Срок оценки: 3 years]
Вторичные конечные точки (11)
  • CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment [Срок оценки: 1 year]
  • CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment [Срок оценки: 5 years]
  • CRC survival and overall survival at 1,3 and 5 years after study treatment [Срок оценки: 1, 3, 5 years]
  • Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 1 year after study treatment [Срок оценки: 1 year]
  • Rate of mild and moderate adverse events classified as grade I and II according to the Clavien Dindo classification at 30 days after study treatment [Срок оценки: 30 days]
  • Length of hospital stay after study treatment [Срок оценки: 30 days]
  • Hospital readmission rate after discharge within 30 days after study treatment [Срок оценки: 30 days]
  • Technical success of the trial procedures, defined as completion of eFTR and surgery as planned with endoscopic complete en-bloc scar excision or complete surgical resection [Срок оценки: 1 day]
  • Duration of the study procedure [Срок оценки: 1 day]
  • Environmental footprint of study procedures at 30 days after study treatment [Срок оценки: 30 days]
  • Health related quality of life and functional outcomes after 30 days and one year [Срок оценки: 30 days, 1 year]

Критерии участия

Критерии включения

  • Men and women, age 40 years or older with endoscopic removal (snare or forceps polypectomy; endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with R1 (resection margin <0.1mm23,40) or Rx resection margins of colon cancer (location proximal to the rectum (12 cm or more from the anal verge))
  • No contraindication for colon surgery as deemed by the multidisciplinary tumor board (MTB) at the participating centre
  • Absence of the following histopathological tumor features: poor differentiation, lymphovascular invasion, tumor budding grade B2-B3.
  • No sign of disease beyond stage T1N0M0 on standard-of-care computed tomography imaging of the thorax, abdomen and pelvis41 and clinical evaluation
  • Identifiable resection site with colonoscopy, either by visualizing a previously administered tattoo or by identification of a scar in the correct colon segment
  • No other tumors or polyps larger than 10 mm in diameter in the colorectum at time of randomization
  • Complete colonoscopy with adequate quality of bowel preparation (Boston Bowel Preparation Scale score ≤2 in all colonic segments) and photo or video documentation of the appendiceal orifice or ileocecal valve.
  • No colonic strictures or severe diverticulosis.
  • No prior CRC
  • No other malignant disease which is not deemed cured
  • No confirmed or suspected genetic cancer syndrome (10 or more adenomas/serrated lesions, adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
  • No inflammatory bowel disease
  • Written informed consent provided by before enrolment

Критерии исключения

  • all who do not fulfill inclusion criteria

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
Простое слепое
Основная цель
Лечение

Центры проведения

Норвегия · 2 центра
  • Vestre Viken Hospital — Oslo
  • Akershus University Hospital — Oslo
Польша · 1 центр
  • Maria Sklodowska-Curie National Research Institute of Oncology — Warsaw

Идентификаторы

NCT: NCT06057350 · REK KULMU-B 613856

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗