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

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyungpook National University; Kyungpook National University Hospital
• Collaborators: Chonnam National University Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Daegu Catholic University Medical Center; Dong-A University Hospital; Hanyang University; Keimyung University Dongsan Medical Center; Korea Cancer Center Hospital; National Cancer Center, Korea; Severance Hospital; Yeungnam University; Yeungnam University Hospital

Criteria

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