Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer

Phase 3

• Conditions: Advanced Gastric Cancer With Serosal Invasion
• Interventions: Procedure: surgery; Drug: adjuvant systemic chemotherapy; Drug: Early postoperative intraperitoneal chemothgerapy

• Registration Number: NCT02205008
• Lead Sponsor: Kyungpook National University Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Status Verified: 2014-07
• Study First Submitted: 2014-07-26
• Study First Submitted QC: 2014-07-29
• Last Update Submitted: 2014-07-29
• Study First Posted: 2014-07-31
• Last Update Posted: 2014-07-31
• Primary Completion: 2015-12
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

1. histologically proven adenocarcinoma of the stomach
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

1. malignancy of the stomach except for adenocarcinoma
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	surgery	curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1
Arm A	adjuvant systemic chemotherapy	curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1
Arm B	adjuvant systemic chemotherapy	curative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1
Arm B	surgery	curative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1
Arm A	Early postoperative intraperitoneal chemothgerapy	curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1

Primary Outcome Measures

Name	Time	Method
relapsed free survival	postoperative 3 years	during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded

Secondary Outcome Measures

Name	Time	Method
overall survival	postoperative 5 years	during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded

Trial Locations

Locations (1)

Kyungpook National University Medical Center Gastric Cancer Center; 🇰🇷 Daegu, Korea, Republic of