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Идёт набор NCT02222844

Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

Без фазы С лечением Cancer Colorectal Neoplasms Colon, Sigmoid Magnetic Resonance Imaging

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: Preoperative MRI scan.
Кому может быть актуально
Состояния в реестре: Cancer, Colorectal Neoplasms, Colon, Sigmoid, Magnetic Resonance Imaging. Базовые параметры: от 16 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
Великобритания
Следующий шаг
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Обзор

Patients with suspected or proven sigmoid colon adenocarcinoma, eligible for curative treatment whose MRI can be reviewed prior to surgery and has no decision regarding radical treatment are eligible. Patient are randomised to the control arm which the standard care of preoperative CT imaging and subsequent discussion by the Multidisciplinary Team or the interventional arm which has the additional use of MRI imaging and subsequent discussion by the Multidisciplinary Team. Patients are followed up at 1 and 3 years together with QoL questionnaires.

Подробное описание

A randomised phase II multicentre trial, IMPRESS will determine whether the use of MRI imaging in staging sigmoid cancers results in a change to the treatment plan by identifying more high risk tumours compared to those patients who were staged using CT imaging. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.

Вмешательства

  • Другое Preoperative MRI scan
    Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.

Первичные конечные точки

  • Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI. [Срок оценки: 3 years after last recruit]
  • Randomised Phase: To measure the difference in treatment stratification policy caused by the difference in staging on CT and MRI. [Срок оценки: 3 years after last recruit]
Вторичные конечные точки (8)
  • To compare the recurrence rates of sigmoid tumours staged by CT and MRI according to predicted prognostic risk. [Срок оценки: 3 years after last recruit]
  • To compare disease free survival of patients staged by CT and MRI according to predicted prognostic risk. [Срок оценки: 1 and 3 years after last recruit]
  • To compare the quality of surgery by pathology of patients staged by CT and MRI according to predicted prognostic risk. [Срок оценки: 5 years]
  • To compare CRM positivity rates on pathology of patients staged by CT and MRI according to predicted prognostic risk [Срок оценки: 3 years after last recruit]
  • To compare baseline and post-treatment stage on imaging against pathology and clinical outcomes of patients staged by CT and MRI. [Срок оценки: 3 years after last recruit]
  • To compare perioperative morbidity and mortality of patients staged by CT and MRI according to predicted prognostic risk. [Срок оценки: 3 years after last recruit]
  • To compare quality of life of patients staged by CT and MRI according to predicted prognostic risk. [Срок оценки: 1 and 3 years after last recruit]
  • To compare permanent defunctioning stoma rates in patients staged by CT and MRI according to predicted prognostic risk. [Срок оценки: 3 years after last recruit]

Критерии участия

Критерии включения

  • Have a suspected or proven sigmoid colon adenocarcinoma
  • Is eligible for curative treatment
  • Has no irresectable metastatic disease
  • MRI can be reviewed by an MDT prior to surgery
  • Has no decision regarding radical treatment
  • Have provided written informed consent to participate in the study
  • Be aged 16 years or over

Критерии исключения

  • Have metastatic disease (including resectable liver metastases)
  • Have a synchronous second malignancy
  • Are contraindicated for MRI
  • Are contraindicated for or have allergy to Buscopan (e.g. glaucoma, small or large bowel obstruction, GFR<30)
  • Have severe co-morbidities or previous medical history that prevent the application of eventual chemo/radiotherapy

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
Диагностика

Центры проведения

Великобритания · 16 центров
  • Hinchingbrooke Hospital — Huntingdon
  • Leighton Hospital — Crewe
  • University Hospital of North Tees — Stockton-on-Tees
  • Croydon University Hospital — Thornton Heath
  • Chesterfield Royal — Chesterfield
  • Queen Alexandra Hospital — Portsmouth
  • St Mark's Hospital — Middlesex
  • Maidstone Hospital — Maidstone
  • … и ещё 8 центров

Идентификаторы

NCT: NCT02222844 · DOCUMAS: 23HH8201

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗