Assessment of a Robotic Distal Gastrectomy on Non-inferiority of N2 Area Nodal Dissection for clinical stage II or III Gastric Cancer (AaRON trial)

CC Hospital0 个研究点目标入组 90 人开始时间: 待定最近更新: 2019年3月11日

试验速览

暂无简介。

•Histologically proven adenocarcinoma of the stomach in patients that have not received any previous treatment for their cancer
•Tumours should be stage II or III according to the UICC 7th edition with no sign of distant metastasis and deemed resectable (R0) by the operating surgeon on preoperative staging by EGD, and CT of abdomen and pelvis
•Location of the tumor at the pylorus, antrum, angle, lower body and midbody to allow subtotal gastrectomy
•Age = 19 years
•Written informed consent

•Performance status =3
•Patients not eligible for surgery (ASA >=4)
•History of another primary cancer, except curatively treated in situ cervical cancer, curatively resected non-melanoma skin cancer. The inclusion of patients with other types of cancer that were successfully treated and did not recur within the last 5 years prior to study enrolment have to be discussed with the principal investigator.
•Evidence of distant metastasis on clinical staging
•Primary tumour deemed unresectable by operating surgeon
•Inadequate organ function as below
•Bone marrow function defined as: (ANC =1.0x109/l, WBC (total) = 2.5x109/l, Platelet Count = 70x109/l, Haemoglobin = 8 g/dl (can be post-transfusion)
•Renal function with serum Creatinine =1.5 mg/dL) ? Liver function defined as (Total Bilirubin= 2.0x (ULN), ALT/AST =2.5x ULN) ? Coagulation profile: with PT (INR) =1.5, aPTT(sec) =1.5xULN
•Women of childbearing potential should have a negative pregnancy test within 7 days prior to commencing treatment, and must take adequate contraceptive precautions
•Simultaneous participation in another clinical trial.

发起方

CC Hospital