None listed
Conditions
Interventions
Procedure/Surgery : ?Arm A : D2 distal subtotal gastrectomy (D2 : Nos.1,3,4sb,4d,5,6,7,8a,9,11p,and 12a nodes) in Japanese classification.
?Arm B
D1+ distal subtotal gastrectomy (D1+ : Nos.1,3,4sb,4d,5,6,7,8a,and 9 nodes) in Japanese classification.
Sponsors
NCC Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (i) histologically proven primary gastric adenocarcinoma, (ii) T1N1, T2N0, T2N1, T3N0, T3N1, which are assessed by computed tomography (CT) scan (AJCC 7th classification) or esophagogastroduodenography (EGD) and intraoperative surgical staging (iii) location of primary tumor; antrum, or angle, , lower body or mid body of the stomach (iv) No evidence of other distant metastasis, (v) age = 20 year old, (vi) performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale, (vii) no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection, (viii) adequate organ functions defined as indicated below: (a) WBC 3000/mm3 – 12,000/mm3, (b) = serum Hemoglobin 8.0 g/dl (c) = serum Platelet 100 000/mm3, (d) < serum AST 100 IU/l, (e) <serum ALT 100 IU/l, (f) < Total Bilirubin 2.0 mg/dl, (g) (ix) written signed informed consent.
Exclusion criteria
Exclusion criteria: (i) active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer), (ii) gastric remnant cancer (iii) =T4a in surgical staging before resection (iv) N2 or more (number of metastatic lymph nodes =3) in CT scan (v) histologically rare variants in WHO Classification such as Adenosquamous, Hepatoid, Squamous cell, Undifferentiated, neuroendocrine carcinoma and others (vi) pregnant or breast-feeding women, (vii) mental disorder(diagnosed with mental disorder on medical record) , (viii) unstable angina or myocardial infarction within 6 months of the trial, (ix) unstable hypertension, (x) severe respiratory disease requiring continuous oxygen therapy (xi) previous upper abdominal surgery except laparoscopic cholecystectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| disease free survival;Subgroup analysis of Laparoscopic surgery versus open surgery;Early postoperative complications;?? ?? ? ???;Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D);Overall cost for the treatment;Finding biomarkers predicting lymph node metastasis and recurrence;OP time;Estimated Blood Loss;Perioperative transfusion rate | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Woo Kim
NCC Hospital
Outcome results
None listed