A Phase Ib/II Study of Efficacy and Feasibility of Cytoreductive Surgery, Extensive Peritoneal Lavage, Hyperthermicintraperitoneal Chemotherapy and Post-operative Intraperitoneal Chemotherapy Combination in Gastric Cancer With Peritoneal Metastasis

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

February 22, 2017

Primary Completion Date

April 19, 2022

Study Completion Date

May 5, 2022

Conditions
Gastric Cancer With Peritoneal Metastasis (PCI<12)
Interventions
DRUG

CRS+HIPEC

"1. Ib~ * Dose-escalation of intraperitoneal paclitaxel will follow a modified 3 + 3 dose escalation procedure.~2. II~ ① CRS If PCI \<12, CRS will be performed by gastrectomy with D2-lymphadenectomy and resection of any involved adjacent structures.~ If PCI≥12, instead of CRS, 3 times of IP paclitaxel +cisplatin and oral S-1 chemotherapy every 3 weeks, and then PCI \<12, CRS will be done.~ ② Extensiveintraperitoneal lavage Peritoneal lavage after CRS will be done with 10 L before HIPEC.~ ③ HIPEC Following surgery HIPEC will be performed using CDDP (60 mg/m2) and PTX (P2RD mg/m2). IP chemotherapy will be performed.~ ④ Post-operative intraperitoneal chemotherapy Postoperative chemotherapy will be done 8 cycles of IP paclitaxel+ cisplatin and oral S-1 after 4 weeks."

Trial Locations (1)

03722

Department of Surgery, Yonsei University College of Medicine, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER

NCT02995850 - A Phase Ib/II Study of Efficacy and Feasibility of Cytoreductive Surgery, Extensive Peritoneal Lavage, Hyperthermicintraperitoneal Chemotherapy and Post-operative Intraperitoneal Chemotherapy Combination in Gastric Cancer With Peritoneal Metastasis | Biotech Hunter | Biotech Hunter