Status:
UNKNOWN
Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer
Lead Sponsor:
Kyungpook National University Hospital
Collaborating Sponsors:
National Cancer Center, Korea
Keimyung University Dongsan Medical Center
Conditions:
Advanced Gastric Cancer With Serosal Invasion
Eligibility:
All Genders
19-70 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2018
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT02205008
Start Date
October 1 2012
End Date
November 1 2018
Last Update
July 31 2014
Active Locations (1)
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1
Kyungpook National University Medical Center Gastric Cancer Center
Daegu, South Korea, 702-210