Идёт набор NCT06761287

Optimizing Patient Selection for Surgery Using Pathologic Analysis Following Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Без фазы С лечением Locally Advanced Rectal Cancer (LARC)

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: Endoscopic resection, Short interval restaging, Total mesorectal excision.
Кому может быть актуально: Состояния в реестре: Locally Advanced Rectal Cancer (LARC). 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: Бельгия
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

Role of Local Endoscopic Excision After Neoadjuvant Therapy in Locally Advanced Rectal Cancer: A Prospective Study

Обзор

This interventional, non-randomized, prospective trial aims to evaluate the role of endoscopic resection following neoadjuvant treatment in patients with locally advanced rectal cancer. Phase I focuses on assessing the feasibility, safety and efficacy of endoscopic resection of residual scar or superficial residual neoplastic tissue following neoadjuvant treatment. Phase II explores the potential of this approach to guide patient selection for total mesorectal excision and to serve as a definitive treatment option for those with limited residual disease.

Вмешательства

Процедура Endoscopic resection
Eligible patients will undergo endoscopic submucosal dissection (ESD) or endoscopic intermuscular dissection (EID) after two to eight weeks of nCRT completion, depending on the used neo-adjuvant regimen. Procedures will be performed using the GIF EZ-1500 endoscope (Olympus America, Center Valley, PA, USA) and an electrosurgical unit (VIO 300 D; Erbe, Germany) to power the electrosurgical knife (1.5-mm DualKnife J, Olympus America). For mucosal incision, Endocut or Drycut mode will be used, while
Поведенческое Short interval restaging
Close follow-up and endoscopic re-evaluation four to eight weeks after the initial evaluation\*. \*Defined as the first endoscopic evaluation after completion of the neoadjuvant treatment
Процедура Total mesorectal excision
This technique consists of the surgical complete removal of the rectum, together with the surrounding mesorectum lymphovascular fatty tissue (mesorectum).

Первичные конечные точки

Feasibility of Endoscopic Resection [Срок оценки: From the endoscopic procedure date to the date of reported pathology results, estimated to a maximum of 15 days]
Disease Recurrence [Срок оценки: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy]

Вторичные конечные точки (10)

Complete endoscopic resection rate [Срок оценки: The day of the endoscopic procedure]
En-bloc endoscopic resection rate [Срок оценки: The day of the endoscopic procedure]
Incidence of procedure-related technical complications (Safety of the technique) [Срок оценки: The day of the endoscopic procedure]
Incidence of early procedure-related adverse events [Срок оценки: Starting the next day following the endoscopic procedure until 30 days after the procedure]
Incidence of late procedure-related adverse events (Long-term safety of the procedure) [Срок оценки: From the endoscopic procedure date until 5 years after the procedure date]
Endoscopic tumor characteristics [Срок оценки: From the endoscopic procedure date until 5 years after the procedure date]
Pathologic tumor characteristics [Срок оценки: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy]
Pathological response [Срок оценки: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy]
Molecular biomarkers [Срок оценки: From the pathologic report date until 5 years after the endoscopic procedure date]
Survival Outcomes [Срок оценки: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy]

Критерии участия

Критерии включения

Age > 18 years old
Signed informed consent
Patients diagnosed with locally advanced rectal cancer showing complete or near-complete clinical response after neoadjuvant therapy without evidence of invasive disease (>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.
Patients diagnosed with locally advanced rectal cancer showing incomplete response with presence of superficial residual lesions, without invasive features on endoscopic evaluation, without evidence of invasive disease (>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.
Without previous medical history of rectal cancer or rectal surgery