[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100413055":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":25,"responsibleParty":35,"collaborators":25,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":25,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":25,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":25,"overallStatus":58,"whyStopped":25,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":25},{"fullName":5,"class":6},"Chonnam National University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Laparoscopic distal gastrectomy","EXPERIMENTAL","Laparoscopic distal gastrectomy after neoadjuvant chemotherapy for the treatment of locally advanced gastric cancer patients",[13],"Procedure: Laparoscopic versus open distal gastrectomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Open distal gastrectomy","ACTIVE_COMPARATOR","Open distal gastrectomy after neoadjuvant chemotherapy for the treatment of locally advanced gastric cancer patients",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Laparoscopic versus open distal gastrectomy","Laparoscopic versus open distal gastrectomy after neoadjuvant chemotherapy for locally advanced gastric cancer",[9,15],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Young-Kyu Park, MD","CONTACT","+82-10-7173-1196","parkyk@jnu.ac.kr",{"name":33,"role":29,"phone":25,"phoneExt":25,"email":34},"Joong-Min Park, MD","jmpark@cau.ac.kr",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Young Kyu Park","Professor","100413055","laparoscopic-vs-open-distal-gastrectomy-after-neoadjuvant-chemotherapy-100413055",false,"NCT04658589","Laparoscopic vs. Open Distal Gastrectomy After Neoadjuvant Chemotherapy","A Multicenter Prospective Phase II Comparative Study of Laparoscopic Versus Open Distal Gastrectomy After Neoadjuvant Chemotherapy for the Treatment of Locally Advanced Gastric Cancer Patients","Inclusion Criteria:\n\n1. Patients who voluntarily expressed their consent to participate in this trial by signing a written 'Subject Consent Form.'\n2. Patients whose gastric adenocarcinoma located in the middle or lower part of the stomach is histologically confirmed and deemed possible to perform a radical distal gastrectomy surgery.\n3. Patients who come under T2\u002FN(+)M0, T3\\~4a\u002FN(- or +) M0 according to the 8th edition of the TNM classification.\n\nExclusion Criteria:\n\n* Methodologies\n\n  1. Patients less than 20 years old or older than 80 years old\n  2. Eastern Cooperative Oncology Group(ECOG) ≥ 2\n  3. Patients with a surgery experience due to a neoplasm in the stomach.\n  4. Patients with complications due to gastric cancer (acute hemorrhage, gastric outlet obstruction or perforation)\n  5. Patients with distant metastases (M1) including distant lymph nodes (Retropancreatic, para-aortic, periportal, retroperitoneal, or mesenteric lymph nodes)\n  6. Patients without distant metastases but who are, according to a surgeon's judgment, unqualified for radical gastrectomy because of invasions to adjacent organs (T4b).\n  7. In the case of localized conglomerated metastatic lymph nodes\n  8. Patients who received surgery or radiation therapy for a primary cancer developed in another organ or those with active\u002Fsynchronous double cancer in recent 5 years.\n  9. Patients who participated in another clinical trial or was administered with a different investigational drug in 30 days prior to randomization.\n  10. Patients who had any of the following in 6 months before the trial recruitment: myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass surgery, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.\n  11. Patients with a previous experience of uncontrolled seizure, central nervous system or psychological disorders whose conditions are clinically significant to the extent that they are unable to express consent to participate in the trial and oral drug administration is not possible.\n  12. Patients with uncontrolled active infection or sepsis.\n  13. Patients who had deep vein thrombosis in recent 4 weeks before the beginning of the trial recruitment.\n  14. Patients with serious acute or chronic disease that can degrade the patient's ability to participate in the trial or impede the interpretation of the trial results.\n  15. Pregnant or breast-feeding patients. Fertile female patients who are positive in pregnancy test.\n\n      Drug Administration for Neoadjuvant Chemotherapy\n  16. Inadequate functions of marrow or organs:\n\n      I. Absolute Neutrophil Count (ANC) \\\u003C 1.5 x 109\u002FL II. Platelet (PLT) \\\u003C 100 x 109\u002FL III. Hemoglobin (Hb) ≤ 9 g\u002FdL IV. AST\\> 2.5 x ULN, ALT\\> 2.5 x ULN V. ALP \\> 2.5 x ULN VI. Total Bilirubin (T. Bil) \\> 1.5 x ULN VII. Serum creatinine (Cr) \\> 1.5 x ULN\n  17. Patients who have peripheral neuropathy with clinical signs of Grade≥2 (NCI CTCAE v4.03) or with absence of deep tension reflex (DTR).\n  18. Patients with hypersensitivity history of the investigational drug (5-FU, Oxaliplatin, Docetaxel).\n  19. Patients who are on treatment with warfarin or coumarin anticoagulants.\n  20. Patients who are on immunosuppressive therapy.\n  21. Patients who are receiving co-medication with Cytochrome P450 2A6 inducer, inhibitor, and substrate.","ALL","20 Years","80 Years",{"count":50,"type":51},238,"ESTIMATED","INTERVENTIONAL",[54],"NA","The study was designed as single-country, multi-center, open-labelled, randomized (1:1), phase II trial.\n\n238 patients with medically and technically operable advanced gastric adenocarcinoma in middle or distal 1\u002F3 of stomach are enrolled and randomly assigned to laparoscopic gastrectomy group and open gastrectomy group. 4 cycles of mFLOT chemotherapy will be conducted before and after gastrectomy.\n\nThe primary objective of this study is comparison of D2 lymph node dissection compliance rate between open surgery group and laparoscopic surgery group after neoadjuvant chemotherapy.",[57],"Stomach Neoplasm","NOT_YET_RECRUITING","2020-12-07",{"date":61,"type":62},"2020-12-08","ACTUAL",{"date":64,"type":51},"2021-01",{"date":66,"type":51},"2026-12",{"name":5,"class":6}]