Anatomical Resection VS. Nonanatomical Resection for Colorectal Liver Metastases With Gene Mutation or Right-sidedness

Официальное название

Anatomical Resection Versus Nonanatomical Resection for Colorectal Liver Metastases Patients With Gene Mutation or Right-sidedness: The ARCLAMP Randomized Controlled Trial

Обзор

In this study, colorectal cancer patients with initially resectable liver-only metastases, as prospectively confirmed by a local multidisciplinary team (MDT) according to predefined criteria, will be tested for RAS and BRAF tumor mutation status. Patients with gene mutant or right-sidedness will be randomised between anatomical resection (AR) or nonanatomical resection (NAR). The primary end-point is the relapse-free survival.

Подробное описание

This study is a prospective, single-center, randomized control trial. The major including criteria are (1) Histologically confirmed colorectal cancer initially resectable liver-only metastases ; (2) patient has the opportunity to perform either anatomical resection (AR) or nonanatomical resection (NAR) surgery; (3) the number of metastasis is 1-3; (4) KRAS/NRAS/BRAF mutation or right-sidedness. Patients will be randomised between AR or NAR. Patients will be stratified for gene mutation and right-sidedness.

Based upon the segmental anatomy of the liver according to Couinaud system, AR is defined as the resection of one or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination thereof. NAR, also called as wedge resection, is defined as the resection of the tumor with a margin of normal parenchyma regardless of the hepatic anatomy.

The primary end-point is the relapse-free survival. The secondary end-points are postoperative complication, postoperative mortality, hospital length of stay, and overall survival.

Вмешательства

• Процедура anatomical liver resection
  Based upon the segmental anatomy of the liver according to Couinaud system, anatomical resection (AR) was defined as resection of 1 or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination of these.
• Процедура nonanatomical liver resection
  Nonanatomical resection(NAR), known as wedge resection, was defined as resection of the tumor with a margin of normal parenchyma without regard to hepatic anatomy.

Первичные конечные точки

• relapse-free survival [Срок оценки: 3 years]

Вторичные конечные точки (4)

• overall survival [Срок оценки: 5 years]
• postoperative hospital stay [Срок оценки: 30 days post operatively]
• postoperative complication [Срок оценки: After surgery during one month]
• postoperative mortality [Срок оценки: After surgery during 90 days]

Критерии участия

Критерии включения

• Age ≥ 18 and ≤ 75 years;
• Histological proof of colorectal adenocarcinoma;
• Resectable colorectal liver metastasis without detectable extrahepatic distant metastatic disease (determined by a local MDT);
• Suitable for anatomical or nonanatomical liver resection (determined by a local MDT);
• Number of metastasis is 1 to 3;
• KRAS/NRAS/BRAF mutation or right-sidedness;
• Performance Status (ECOG) 0\~1;
• Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization);
• Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, serum transaminases ≤ 5x upper limit of normal(ULN), and serum creatinine ≤ 1.5x ULN and creatinine clearance ≥ 30 ml/min;
• Written informed consent.

Критерии исключения

• Previous systemic treatment for metastatic disease;
• Previous surgery for metastatic disease;
• Extrahepatic metastases;
• Unresectable primary tumor;
• Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;
• Second primary malignancy within the past 5 years;
• Acute or subacute intestinal obstruction;
• Drug or alcohol abuse;
• No legal capacity or limited legal capacity;
• Pregnant or lactating women.

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

Китай · 1 центр

• Zhongshan hospital — Шанхай

Идентификаторы

NCT: NCT05881746 · ARCLAMP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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