Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer
Conditions
Advanced Gastric Cancer With Serosal Invasion
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
advanced gastric cancer, serosal invasion, peritoneal recurrence, intraperitoneal chemotherapy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: surgery Type: Procedure
Name: adjuvant systemic chemotherapy Type: Drug
Name: Early postoperative intraperitoneal chemothgerapy Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 19 Years
Gender: Both
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
Location
Kyungpook National University Medical Center Gastric Cancer Center
Daegu, Korea, Republic of
Status: Recruiting
Contact: Wansik Yu, MD, PhD - 82-53-200-2700 - wyu@nknu.ac.kr
Start Date
October 2012
Completion Date
November 2018
Sponsors
Kyungpook National University
Source
Kyungpook National University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page