Gastric cancer with positive is defined as stage IV disease in 7th AJCC/UICC TNM staging system. Controversy exists on the treatment of this part of patients. This trial aimed to explore the optimal treatment strategy for stage IV gastric cancer with positive peritoneal cytology as the only non-curable factor.
In the 7th AJCC/UICC TNM staging system, gastric cancer with positive peritoneal cytology (CY+) is defined as stage IV disease. In NCCN clinical practice guidelines, it is suggested that positive peritoneal cytology in the absence of visible peritoneal implants should be considered as M1 disease and surgery as initial treatment is not recommended for patients with positive peritoneal cytology. However, in the Japanese gastric cancer treatment guidelines 2014, it is suggested that standard gastrectomy can be proposed for patients with no other non-curative factors and if the CY+ status was revealed after surgery, postoperative treatment with S-1 can be recommended as the tentative standard. Previous studies have also proved that extensive intraperitoneal lavage(EIPL) and Hyperthermic Intraperitoneal Chemotherapy(HIPEC) are effective methods for the treatment of peritoneal metastasis. In order to optimize the treatment strategy of this part of patients, this trial is designed to compare the effectiveness of 2 treatment strategies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
standard distal or total gastrectomy and accorded D2 lymphadenectomy
Intraperitoneal docetaxel of 100mg/m2 at 42℃ for 30 minutes
Lavage of peritoneal cavity with 1000ml saline for 10 times
Gastrointestinal Cancer Center, Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Overall survival
Time frame: 3 year
peritoneal recurrence rate
Time frame: 3 year
Recurrence free survival
Time frame: 3 year
rate of peritoneal cytology converted to negative
Time frame: 7 days After the second time laparoscopic staging and peritoneal cytology examination
morbidity and mortality of HIPEC and EIPL
Time frame: 30 days after HIPEC and EIPL procedures
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Oxaliplatin 130mg/m2 D1 S-1 40-60mg Bid D1-14 Repeated every 3 weeks.
SOX regimen postoperative chemotherapy (Oxaliplatin 130mg/m2 D1, S-1 40-60mg Bid D1-14, Repeated every 3 weeks) for surgery-first arm. Regimen for chemotherapy-first arm is determined according to the postoperative pathologic evaluation of response.