None listed
Conditions
Interventions
Procedure/Surgery : laparoscopic versus open distal gastrectomy
Sponsors
Chonnam National University Hospital Hwasun Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who voluntarily expressed their consent to participate in this trial by signing a written ‘Subject Consent Form.’ 2. 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. 3. Patients who come under T2/N(+)M0, T3~4a/N(- or +) M0 according to the 8th edition of the TNM classification.
Exclusion criteria
Exclusion criteria: Methodologies 1. Patients less than 20 years old or older than 80 years old 2. Eastern Cooperative Oncology Group(ECOG) = 2 3. Patients with a surgery experience due to a neoplasm in the stomach. 4. Patients with complications due to gastric cancer (acute hemorrhage, gastric outlet obstruction or perforation) 5. Patients with distant metastases (M1) including distant lymph nodes (Retropancreatic, para-aortic, periportal, retroperitoneal, or mesenteric lymph nodes) 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). 7. In the case of localized conglomerated metastatic lymph nodes 8. Patients who received surgery or radiation therapy for a primary cancer developed in another organ or those with active/synchronous double cancer in recent 5 years. 9. Patients who participated in another clinical trial or was administered with a different investigational drug in 30 days prior to randomization. 10. Patients who had any of the following in 6 months before the trial recruitment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass surgery, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack. 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. 12. Patients with uncontrolled active infection or sepsis. 13. Patients who had deep vein thrombosis in recent 4 weeks before the beginning of the trial recruitment. 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. 15. Pregnant or breast-feeding patients. Fertile female patients who are positive in pregnancy test. Drug Administration for Neoadjuvant Chemotherapy 16. Inadequate functions of marrow or organs: I. Absolute Neutrophil Count (ANC) < 1.5 x 109/L II. Platelet (PLT) < 100 x 109/L III. Hemoglobin (Hb) = 9 g/dL 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 17. Patients who have peripheral neuropathy with clinical signs of Grade=2 (NCI CTCAE v4.03) or with absence of deep tension reflex (DTR). 18. Patients with hypersensitivity history of the investigational drug (5-FU, Oxaliplatin, Docetaxel). 19. Patients who are on treatment with warfarin or coumarin anticoagulants. 20. Patients who are on immunosuppressive therapy. 21. Patients who are receiving co-medication with Cytochrome P450 2A6 inducer, inhibitor, and substrate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of harvested lymph nodes in D2 lymph node dissection | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 year progression free survival: PFS is defined as time from the point of randomization to objective tumor progression or relapse, or to death according to RECIST 1.1.;3 year relapse free survival: RFS is defined as time from the point of randomization to tumor relapse or death;Completeness of planned chemotherapy: Defined as the ratio of dosing regimen cycles that are completed according to neoadjuvant or adjuvant chemotherapy schedules;Comparison of postoperative morbidity and mortality: Defined as the incidence of complications within 30 days after surgery and death within 90 days. Classification and severity of the complications shall be based on that of KLASS-02-RCT.;Curative resection rate: Defined as a case where complete removal of all tumors were confirmed through gross or microscopic examination; negative resection margin was obtained; and, D2 lymph node dissection was performed.;Conversion to open surgery: Defined as a case where the operation was converted to an open surgery because of reasons including combined organ resection due to adjacent organ invasion, severe intra-abdominal adhesion, or serious intraoperative bleeding. These shall not construct a reason for dropout from the trial and shall be included in the ITT group for analysis. | — |
Countries
Korea, Republic of
Contacts
Public ContactJoong-Min Park
Chung-Ang Univerisity Hospital
Outcome results
None listed