Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 44
- 主要终点
- Intrahepatic disease-free survival (iDFS)
研究概览
简要总结
the ARMANI trial will test the hypothesis, if an anatomic resection (AR) improves long-term outcome vs. a non-anatomical resection (NAR) in patients undergoing surgery for RAS-mutated colorectal liver metastasis (CRLM).
详细描述
Despite increasing application and success of personalized treatment in medical oncology, little progress has been made in personalized surgical cancer therapy. The ARMANI trial presents the first prospective, randomized trial to evaluate effectiveness and safety of molecular-guided resection in patients with colorectal liver metastasis (CRLM). While CRLM might be removed independently of the liver's segmental borders, retrospective data favor anatomic resections in the subgroup of patients with a mutation in the RAS oncogene. Therefore, the ARMANI trial will test the hypothesis, if an anatomic resection (AR) improves long-term outcome vs. a non-anatomical resection (NAR) in patients undergoing surgery for RAS-mutated CRLM. The trial will be carried out among 11 high-volume centers of hepato-biliary surgery in Germany. A total of 220 patients will be enrolled and randomized in a 1:1 ratio to undergo an AR vs. NAR. The primary endpoint is intrahepatic disease-free survival (iDFS). In addition, the study will provide important data on perioperative outcomes and quality of life for both surgical techniques. Given the trend among liver surgeons to aim for parenchymal-sparing operations to preserve liver parenchyma, a positive trial will be practice changing and present the first piece of high-level evidence on benefits of personalized surgical therapy guided by the tumor's mutational profile in patients with CRLM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colorectal cancer with RAS mutation (KRAS or NRAS)
- •Colorectal liver metastases (single or multiple)
- •Planned R0 resection of liver metastases (and primary tumor, if present)
- •Anatomical and non-anatomical liver resection technically feasible
- •Male and female patients, age ≥ 18 years
- •Written informed consent
排除标准
- •Extrahepatic metastases
- •Planned staged liver resection (e.g. two-stage hepatectomy)
- •Diagnosis of another cancer < 5 years prior to randomization Exceptions: curatively treated in situ cervical cancer, curatively resected non-melanoma skin cancer
- •Expected lack of compliance
- •Addiction or other illnesses which do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences
结局指标
主要结局
Intrahepatic disease-free survival (iDFS)
时间窗: 24 months
Time from operation date to date of disease recurrence in the liver, followed up at intervals of three months for a maximum duration of 24 months or until death. Any new, solid lesion in the liver after resection of all CRLM that fulfils imaging criteria (CT, MRI) of a metastasis is counted as an iDFS event.
次要结局
- Assessment of additional oncological and perioperative outcomes: Transfusion of blood, transfused packed red blood cells (PRBC), fresh frozen plasma (FFP) and / or platelet concentrate (PC) [units](48 hours after surgery)
- Assessment of additional oncological and perioperative outcomes: Duration of postoperative hospital stay [days](At day of discharge, assessed up to 90 days)
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Platelet count(pre-operatively, 5 days after surgery)
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Albumin(pre-operatively, 5 days after surgery)
- Assessment of additional oncological and perioperative outcomes: Duration of postoperative intermediate/intensive care unit stay [days](At day of discharge, assessed up to 90 days)
- Assessment of additional oncological and perioperative outcomes: 90-day mortality(90 days after surgery)
- Assessment of additional oncological and perioperative outcomes: Kind of peri-operative morbidity after resection(90 days after surgery)
- Assessment of additional oncological and perioperative outcomes: Intraoperative blood loss [mL](During surgery)
- Assessment of additional oncological and perioperative outcomes: Operating time [min](During surgery)
- Assessment of additional oncological and perioperative outcomes: Frequency of peri-operative morbidity after resection(90 days after surgery)
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: aspartate-aminotransferase(pre-operatively, 5 days after surgery)
- Assessment of additional oncological and perioperative outcomes: Frequency invasive re-interventions(30 days after surgery)
- Assessment of additional oncological and perioperative outcomes: Frequency of Overall survival (OS)(24 month)
- Assessment of additional oncological and perioperative outcomes: Kind of oncological Re-interventions [y/n](24 month)
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Alanine-aminotransferase(pre-operatively, 5 days after surgery)
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Gamma-glutamyl transferase(pre-operatively, 5 days after surgery)
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: International normalized ratio(pre-operatively, 5 days after surgery)
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Total bilirubin(pre-operatively, 5 days after surgery)
- Assessment of additional oncological and perioperative outcomes: Frequency of cancer-specific survival (CSS)(24 months)
- Assessment of additional oncological and perioperative outcomes: Frequency of oncological Re-interventions [y/n](24 month)
- Assessment of additional oncological and perioperative outcomes: Kind of invasive re-interventions(30 days after surgery)
- Assessment of additional oncological and perioperative outcomes: Administration of adjuvant therapy [y/n](24 month)
- Assessment of additional oncological and perioperative outcomes: Number of patients with positive resection margins(During surgery)
- Assessment of additional oncological and perioperative outcomes: Frequency of disease-free survival (DFS)(24 month)
- Assessment of additional oncological and perioperative outcomes: Assessment of "Quality of life" (QoL)(12 month)