This is an open-label, non-randomized, single-center, phase Ib/II study, evaluating efficacy and feasibility of cytoreductive surgery(CRS), extensive peritoneal lavage, hyperthermic intraperitoneal chemotherapy(HIPEC) and post-operative intraperitoneal chemotherapy combination in gastric cancer with peritoneal metastasis
Peritoneal metastases in gastric cancer are considered to indicate terminal disease due to poor prognosis because systemic chemotherapy is unlikely to accumulate in peritoneal nodules in cytotoxic concentrations. Cytoreductive surgery (CRS) along with hyperthermic intraperitoneal chemotherapy (HIPEC) has been suggested to improve survival in select patients with limited peritoneal spread, resulting in a median overall survival (OS) of 8 to 14 months. It remains unclear, however, which regimen is best and who have benefits from CRS and HIPEC. Herein, we has conducting prospective phase Ib/II trial of CRC and HIPEC with intraperitoneal paclitaxel and cisplatin, and oral S-1 in gastric cancer with peritoneal metastasis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
25
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.
Department of Surgery, Yonsei University College of Medicine
Seoul, South Korea
Ib: Maximum tolerate dose
Ib: To determine the MTD of orally administered S-1 + intraperitoneal paclitaxel +cisplatin in gastric cancer with peritoneal metastasis.
Time frame: 3 months
II: Safety
II:To assess the safety and tolerability of CRS +HIPEC (Clavien-Dindo classification of surgical complication \& NCI-common terminology criteria for adverse events(CTC-AE) for chemotherapy\]
Time frame: 3 months
OS (overall survival)
the length of time from the patient signing the consent form until the patient is still alive
Time frame: 12 months
PFS (Progression-free survival)
the length of time from the patient signing the consent form until the patient shows disease progression
Time frame: 12 months
RR (response rate)
the proportion of complete response to partial response These will be estimated by the Kaplan-Meire method.
Time frame: 12 months
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