Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer
Summary
Intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. Although we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal chemotherapy have been published. In this study, we review the clinicopathological characteristics of patients and effects of early postoperative intraperitoneal chemotherapy (EPIC) on overall and gastric cancer-specific survival and patterns of recurrence of gastric cancer patients with macroscopic serosal invasion. The aim of this study is to evaluate the impact of intraperitoneal chemotherapy on overall and disease free survival of advanced gastric cancer patients with serosal invasion after potentially curative surgery.
Timeline
- Start
- 2012-10
- Primary completion
- 2015-12
- Completion
- 2018-11
Publications
- Background 1. Maruyama K, Okabayashi K, Kinoshita T. Progress in gastric cancer surgery in Japan and its limits of radicality. World J Surg 1987;11:418-425. 2. Lee JL, Kang HJ, Kang YK, et al. Phase I/II study of 3-week combination of S-1 and cisplatin chemotherapy for metastatic or recurent gastric cancer. Cancer Chemother Pharmacol 2007 (E-pub). 3. Schoffski P. The modulated oral fluoropyrimidine prodrug S-1, and its use in gastrointestinal cancer and other solid tumors. Anticancer Drug 2004;15:85-106. 4. Sugimachi K, Maehara Y, Horikoshi N et al. An early phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. Oncology 1999;57:202-210. 5. Koizumi W, Kurihara M, Nakajo S et al. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. Oncology 2000;58:191-197. 6. Sakata Y, Ohtsu A, Horikoshi N et al. Late phase II study of novel oral fluoropyrimidine anticancer drugs S-1 (1 M tegafur-0.4 M gimestat-1 M otastat potassium) in advanced gastric cancer patients. Eur J Cancer 1998;34:1715-1720. 7. Nagashima F, Ohtsu A, Yoshida S et al. Japanese nationwide postmarketing survey of S-1 in patients with advanced gastric cancer. Gastric Cancer 2005;8:6-11. 8. Chollet P, Schoffski P, Weigang-Kohler K et al. Phase II trial with S-1 in chemotherapy-naïve patients with gastric cancer. A trial performed by the EORTC early clinical studies group (ECGC). Eur J Cancer 2003;39:1264-1270. 9. Ilson D. Just when you thought the fluorouracil debate was over: S-1 and gastric cancer. J Clin Oncol 2005;23:6826-6828. 10. Hoff PM, Saad ED, Ajani JA et al. Phase I study with pharmacokinetics of S-1, an oral daily schedule for 28 days in patients with solid tumors. Clin Cancer Res 2003;9:134-142. 11. Simon R. Optimal two-stage design for phase II clinical trials. Controlled Clin Trials 1989;10:1-10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitomycin C | Other / unclassified | 10 mg/m2 | Other |
| Subject | fluorouracil | Small molecule | 700 mg/m2 | Other |
| Background | S-1 | Small molecule | 40 mg | — |
| Background | S-1 | Small molecule | 50 mg | — |
| Background | S-1 | Small molecule | 60 mg | — |
| Background | sodium bicarbonate | Diagnostic / imaging agent | 50 meq | Other |