- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02205008
Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer (EPIC-GC)
Prospective Randomized Multicenter Phase III Trial of Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Wansik Yu, MD, PhD, FACS
- Phone Number: 82-53-200-2700
- Email: wyu@knu.ac.kr
Study Locations
-
-
-
Daegu, Korea, Republic of, 702-210
- Recruiting
- Kyungpook National University Medical Center Gastric Cancer Center
-
Contact:
- Wansik Yu, MD, PhD
- Phone Number: 82-53-200-2700
- Email: wyu@nknu.ac.kr
-
Principal Investigator:
- Wansik Yu, MD, PhD
-
Sub-Investigator:
- Oh Kyoung Kwon, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- histologically proven adenocarcinoma of the stomach
- preoperative suspicion of serosal invasion on the radiological examination
- candidate for curative resection of the stomach with D2
- age from 19 to 70 year old
- Eastern Cooperative Oncology Group Performance status :0, 1, or 2
- absolute neutrophil count≥1,500/microliter, hemoglobin≥9.0g/dL, and platelet≥100,000/microliter
- serum Creatinine<1.5mg/dL
- total bilirubin <2 x upper normal limit, transaminase<3 x upper normal limit
- patients without previous administration of chemotherapeutic agent
- patients who agreed and signed to the informed consent form
Exclusion Criteria:
- malignancy of the stomach except for adenocarcinoma
- history of hypersensitivity to 5-fluorouracil or mitomycin
- concomitant infectious disease
- active hepatitis or chronic liver disease
- history of psychotic disorders
- patients with disorders in the central nervous system
- history of other malignancy within 5 years
- history of clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, symptomatic arrhythmia, myocardial infarction)
- patients with increased bleeding tendency
- pregnant or lactating female patients
- patient who did not agreed and signed to the informed consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A
curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1
|
Total or subtotal gastrectomy with D2
adjuvant systemic chemotherapy with S-1 (<1.25m2:40mg, 1.25-1.5m2:50mg,
>1.5m2:60mg, bid)
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 |
Placebo Comparator: Arm B
curative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1
|
Total or subtotal gastrectomy with D2
adjuvant systemic chemotherapy with S-1 (<1.25m2:40mg, 1.25-1.5m2:50mg,
>1.5m2:60mg, bid)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
relapsed free survival
Time Frame: postoperative 3 years
|
during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded
|
postoperative 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: postoperative 5 years
|
during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded
|
postoperative 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
surgery and intraperitoneal chemotherapy-related morbidity and mortality
Time Frame: postoperative 30days
|
In hospital complication related to surgery or intraperitoneal chemotherapy will be recored and analyzed to evaluate the safety of intraperitoneal chemotherapy.
|
postoperative 30days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Wansik Yu, MD. PhD, Kyungpook National University Medical Center
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPIC-GC
- KNUMCGCC-001 (Other Identifier: KNUMC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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