Malignant Neoplasm of Stomach Clinical Trial
Official title:
Prospective Phase III Trial Using Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients Including Adenocarcinoma of the Esophagogastric Junction
Patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients randomized into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and are followed up for 24 months.
The objective of the trial is to compare the treatment of patients with advanced gastric
cancer without evidence of distant metastases treated with D2 radical gastrectomy and
intraperitoneal chemoperfusion (HIPEC) and postoperative chemotherapy (Group B) and patients
treated with D2 radical gastrectomy alone and postoperative chemotherapy (Group A).
The hypothesis of the trial is that D2 radical gastrectomy with intraperitoneal
chemoperfusion (Group B) is superior to D2 radical gastrectomy (Group A) in terms of overall
survival.
The trial is designed as a prospective, randomized, open, multicenter and parallel group
study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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