Clinical trial · Interventional
Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer
A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer
NCT01088204CI-TRIAL-00019373COACT_1001unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laparoscopy assisted distal gastrectomy | Procedure | — | UNRESOLVED |
| open distal gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- open distal gastrectomy
- description
- open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
- interventionNames
- Procedure: open distal gastrectomy
- type
- EXPERIMENTAL
- label
- laparoscopy assisted distal gastrectomy
- description
- laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
- interventionNames
- Procedure: laparoscopy assisted distal gastrectomy
Primary outcomes (1)
- measure
- noncompliance rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDPark YK, Yoon HM, Kim YW, Park JY, Ryu KW, Lee YJ, Jeong O, Yoon KY, Lee JH, Lee SE, Yu W, Jeong SH, Kim T, Kim S, Nam BH; COACT group. Laparoscopy-assisted versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: Results From a Randomized Phase II Multicenter Clinical Trial (COACT 1001). Ann Surg. 2018 Apr;267(4):638-645. doi: 10.1097/SLA.0000000000002168. PMID 28187041
- DERIVEDNam BH, Kim YW, Reim D, Eom BW, Yu WS, Park YK, Ryu KW, Lee YJ, Yoon HM, Lee JH, Jeong O, Jeong SH, Lee SE, Lee SH, Yoon KY, Seo KW, Chung HY, Kwon OK, Kim TB, Lee WK, Park SH, Sul JY, Yang DH, Lee JS. Laparoscopy Assisted versus Open Distal Gastrectomy with D2 Lymph Node Dissection for Advanced Gastric Cancer: Design and Rationale of a Phase II Randomized Controlled Multicenter Trial (COACT 1001). J Gastric Cancer. 2013 Sep;13(3):164-71. doi: 10.5230/jgc.2013.13.3.164. Epub 2013 Sep 30. PMID 24156036