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| ID | Type | Description | Link |
|---|---|---|---|
| KNUMCGCC-001 | Other Identifier | KNUMC |
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| Name | Class |
|---|---|
| National Cancer Center, Korea | OTHER_GOV |
| Keimyung University Dongsan Medical Center | OTHER |
| Yeungnam University Hospital | OTHER |
| Daegu Catholic University Medical Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1 |
|
| Arm B | Placebo Comparator | curative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgery | Procedure | Total or subtotal gastrectomy with D2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| relapsed free survival | during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded | postoperative 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded | postoperative 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| surgery and intraperitoneal chemotherapy-related morbidity and mortality | In hospital complication related to surgery or intraperitoneal chemotherapy will be recored and analyzed to evaluate the safety of intraperitoneal chemotherapy. | postoperative 30days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wansik Yu, MD, PhD, FACS | Contact | 82-53-200-2700 | wyu@knu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Wansik Yu, MD. PhD | Kyungpook National University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Medical Center Gastric Cancer Center | Recruiting | Daegu | 702-210 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. |
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| OTHER |
| Chonnam National University Hospital | OTHER |
| Dong-A University Hospital | OTHER |
| Severance Hospital | OTHER |
| Korea Cancer Center Hospital | OTHER |
| Chung-Ang University Hospital | OTHER |
| Hanyang University | OTHER |
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| adjuvant systemic chemotherapy |
| Drug |
adjuvant systemic chemotherapy with S-1 (<1.25m2:40mg, 1.25-1.5m2:50mg, >1.5m2:60mg, bid) |
|
| Early postoperative intraperitoneal chemothgerapy | Drug | operation day: 0.9％ saline solution 1L plus mitomycin C 10 mg/m2 1 - 4 postoprative day: 0.9％ saline solution 1L plus 5-FU 700 mg/m2 plus sodium bicarbonate 50 mEq |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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