Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer

Launched by NATIONAL CANCER CENTER, KOREA · Mar 16, 2010

Keywords

ClinConnect Summary

To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • histologically proven primary gastric adenocarcinoma
• • T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location
• • No evidence of other distant metastasis
• • not stump carcinoma,(vi) aged 20-80 year old
• • performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
• • no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection
• * adequate organ functions defined as indicated below:
• • WBC 3000/mm3, WBC 12 000/mm3
• • Hb 8.0 g/dl without any transfusion 2 weeks before enrollment
• • Plt 100 000/mm3
• • AST 100 IU/l
• • ALT 100 IU/l
• • T.Bil 2.0 mg/dl
• • written informed consent
• Exclusion Criteria:
• • 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)
• • pregnant or breast-feeding women
• • severe mental disorder
• • systemic administration of corticosteroids
• • unstable angina or myocardial infarction within 6 months of the trial
• • unstable hypertension
• • severe respiratory disease requiring continuous oxygen therapy
• • previous upper abdominal surgery except laparoscopic cholecystectomy