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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003135

Enrollment

Registered

2018-08-28

Start date

2015-12-22

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Distal Gastrectomy with D2 LND

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Number of retrieved lymph nodes in the topographical N2 area	—

Secondary

Measure	Time frame
5-year Overall-survival;3-year Recurrence-free survival;Incidence of local recurrence	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Woo Kim

NCC Hospital

gskim@ncc.re.kr+82-31-920-1635

Outcome results