Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer
NCT ID: NCT02205008
Last Updated: 2014-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
230 participants
INTERVENTIONAL
2012-10-31
2018-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1
surgery
Total or subtotal gastrectomy with D2
adjuvant systemic chemotherapy
adjuvant systemic chemotherapy with S-1 (\<1.25m2:40mg, 1.25-1.5m2:50mg, \>1.5m2:60mg, bid)
Early postoperative intraperitoneal chemothgerapy
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
Arm B
curative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1
surgery
Total or subtotal gastrectomy with D2
adjuvant systemic chemotherapy
adjuvant systemic chemotherapy with S-1 (\<1.25m2:40mg, 1.25-1.5m2:50mg, \>1.5m2:60mg, bid)
Interventions
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surgery
Total or subtotal gastrectomy with D2
adjuvant systemic chemotherapy
adjuvant systemic chemotherapy with S-1 (\<1.25m2:40mg, 1.25-1.5m2:50mg, \>1.5m2:60mg, bid)
Early postoperative intraperitoneal chemothgerapy
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
Eligibility Criteria
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Inclusion Criteria
2. preoperative suspicion of serosal invasion on the radiological examination
3. candidate for curative resection of the stomach with D2
4. age from 19 to 70 year old
5. Eastern Cooperative Oncology Group Performance status :0, 1, or 2
6. absolute neutrophil count≥1,500/microliter, hemoglobin≥9.0g/dL, and platelet≥100,000/microliter
7. serum Creatinine\<1.5mg/dL
8. total bilirubin \<2 x upper normal limit, transaminase\<3 x upper normal limit
9. patients without previous administration of chemotherapeutic agent
10. patients who agreed and signed to the informed consent form
Exclusion Criteria
2. history of hypersensitivity to 5-fluorouracil or mitomycin
3. concomitant infectious disease
4. active hepatitis or chronic liver disease
5. history of psychotic disorders
6. patients with disorders in the central nervous system
7. history of other malignancy within 5 years
8. history of clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, symptomatic arrhythmia, myocardial infarction)
9. patients with increased bleeding tendency
10. pregnant or lactating female patients
11. patient who did not agreed and signed to the informed consent form
19 Years
70 Years
ALL
No
Sponsors
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National Cancer Center, Korea
OTHER_GOV
Keimyung University Dongsan Medical Center
OTHER
Yeungnam University Hospital
OTHER
Daegu Catholic University Medical Center
OTHER
Chonnam National University Hospital
OTHER
Dong-A University Hospital
OTHER
Severance Hospital
OTHER
Korea Cancer Center Hospital
OTHER
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Hanyang University
OTHER
Kyungpook National University Hospital
OTHER
Responsible Party
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Wansik Yu
professor
Principal Investigators
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Wansik Yu, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Kyungpook National University Medical Center
Locations
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Kyungpook National University Medical Center Gastric Cancer Center
Daegu, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Wansik Yu, MD, PhD
Role: primary
References
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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.
Other Identifiers
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KNUMCGCC-001
Identifier Type: OTHER
Identifier Source: secondary_id
EPIC-GC
Identifier Type: -
Identifier Source: org_study_id