Stomach Neoplasm Clinical Trial
Official title:
Treatment Strategy for Stage IV Gastric Cancer With Positive Peritoneal Cytology as the Only Non-curable Factor (Cy-plus): a Phase 2, Randomized Controlled Trial
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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