Идёт набор NCT02292641

Beyond TME Origins

Без фазы С лечением Neoplasms Adenocarcinoma Carcinoma

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: New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery.
Кому может быть актуально: Состояния в реестре: Neoplasms, Adenocarcinoma, Carcinoma. 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: Норвегия, Великобритания
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

Investigating the Origins of Pelvic Recurrence in Colorectal Cancer

Обзор

All patients with recurrent colorectal cancer in the pelvis are eligible. The original primary tumour staging scans and resected surgical specimen needs to be available. Patients' recurrence will be staged using our proposed MRI classification. We will be assessing the original primary staging scans and histopathology to learn about risk factors for recurrence. We will record treatment for the recurrence, and patients will be followed up for three years.

Подробное описание

A prospective and retrospective cohort study to improve surgical and treatment planning using an imaging assessment proforma of advanced and recurrent colorectal cancers. This involves the implementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning.

Вмешательства

Процедура New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery
Currently there are no validated criteria or guidelines for judging whether advanced primary or recurrent colorectal cancer can be successfully removed and for selecting which patients should undergo this form of more radical surgery as is exenterative surgery. We are proposing that by validating the detailed evaluation of imaging of the tumour distribution within the pelvis using a new radiological staging classification, this will enable clear selection criteria to be established and will impr

Первичные конечные точки

To change R0 resection rates for locally recurrent rectal cancers with the use of the proposed staging system. [Срок оценки: 3 years]

Вторичные конечные точки (8)

To compare baseline prognostic features against type of recurrence [Срок оценки: 3 and 5 years]
To compare the MRI type of recurrence against clinical outcomes [Срок оценки: 1, 3 and 5 years]
To compare the MRI compartment(s) distribution of recurrence against clinical outcomes [Срок оценки: 1, 3 and 5 years]
To investigate the effect of surgical and non-surgical treatments for recurrence on Quality of Life [Срок оценки: 1, 2, 3 and 5 years]
To compare radiology and histopathology compartments in patients undergoing beyond TME surgery for recurrence [Срок оценки: Up to 2 years]
To measure radiology inter-observer agreement for types of recurrence classification [Срок оценки: 5 years]
To investigate health economic costs of patients with pelvic recurrence against type [Срок оценки: Up to 3 years]
To map original radiotherapy volumes (including integrated boosts) against types of recurrence [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

Had a primary colorectal adenocarcinoma proven by biopsy taken as part of routine clinical practice
Has a confirmed diagnosis of recurrent pelvic colorectal cancer
Has previously completed surgical treatment of primary adenocarcinoma of the colon, sigmoid colon or rectum
Are able to undergo high resolution MRI for staging prior to treatment decisions
Have provided written informed consent to participate in the study
Be aged 16 years or over

Критерии исключения

Have irresectable extra-pelvic metastatic disease
Original baseline staging and preoperative restaging scans (MR for rectal and sigmoid cancers and/or CT for colon and sigmoid cancers) are unavailable
Original preoperative, surgical and adjuvant treatment has not been documented or is unavailable

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

Здоровые добровольцы: Нет