Assessment of a Robotic Distal Gastrectomy on Non-inferiority of N2 Area Nodal Dissection for clinical stage II or III Gastric Cancer (AaRON trial)
- Conditions
- Neoplasms
- Registration Number
- KCT0003135
- Lead Sponsor
- CC Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of retrieved lymph nodes in the topographical N2 area
- Secondary Outcome Measures
Name Time Method 5-year Overall-survival;3-year Recurrence-free survival;Incidence of local recurrence