The results of the current studies to determine the optimal strategy for metastatic gastric cancer remain contrversial worldwide.
Hypothesis: Cytoreductive Gastrectomy After Systemic Therapy will improve survival time for metastasis gastric cancer compared to Systemic Therapy alone.
Age 18-75
GCLM detected on surgical exploration and demonstrated by histology or cytology
Localized peritoneal carcinomatosis (P1 or P2 score), according to the classification of the Japanese Research Society for Gastric Cancer
Liver metastasis lesions of maximum diameter ≤5 cm
Any extra-abdominal metastasis at diagnosis or during systemic treatment.
Past history of malignancy other than gastric cancer diagnosed in the last 5 years except for basal cell carcinoma of skin or preinvasive cancer of cervix
Patients in the reproductive age who declined to use an adequate means of contraception
Significant disease or conditions which, in the investigator's opinion, would exclude patient from the study
Parallel
Cytoreductive Gastrectomy
Procedure/SurgeryThe patients undergo gastrectomy after 4 cycles of systemic therapy
Median survival time
the median length of time from the date of randomization to death from any cause or to the last follow-up for a surviving patient the median length of time from the date of randomization to death from any cause or to the last follow-up for a surviving patient
Progression-free survival (PFS)
Time interval from randomization to either radiological/clinical recurrence (Arm 1) or progression (Arm 2) or death from any cause. Patients who remained alive and without recurrence at the time of analysis or who are lost to follow-up will be censored at the date last seen
Overall survival (OS
the time interval from randomization to death from any cause. Patients who remained alive at the time of analysis or who are lost to follow-up will be censored at the date last seen and intention-to-treat analysis will be performed
Cytoreductive completenes of peritonectomy (for Arm 1)
The compleness of peritonectomy * CC-0: no peritoneal seeding visualized within the operative field * CC-1 indicates nodules persisting after cytoreduction less than 2.5 cm * CC-2 has nodules between 2.5 and 5 cm * CC-3 indicates nodules greater than 5 cm or a confluence of unresectable tumor nodule at any site within the abdomen or pelvis.
R0 resection rate (for Arm 1)
Percentage of cases achiving R0 resection after cytoreductive surgery. Curability after conversion surgery (R0/R1/R2) defined as: * R2 surgery: macroscopically positive residual tumor at margins, invasive lesion, other metastatic lesions; or cytoreductive completeness of 1-3 when performing peritonectomy * R1 surgery: no R2 criteria; microscopically positive margins, or positive cytology lavage after gastrectomy, or finding of malignant lesion in the 3-month postoperative imaging * R0 surgery: no R1 or R2 surgery, and no finding of malignant lesion in thẻ 3-month postoperative imaging
Early complication rate (Arm 1)
Rate of any complications happened intraoperative and 30-days post-operative, classified by Clavien - Dindo classification
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