Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer (EPIC-GC)

Kyungpook National University

Status and phase: Unknown; Phase 3

Conditions: Advanced Gastric Cancer With Serosal Invasion

Treatments: Drug: Early postoperative intraperitoneal chemothgerapy; Drug: adjuvant systemic chemotherapy; Procedure: surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02205008

EPIC-GC

KNUMCGCC-001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

230 participants in 2 patient groups, including a placebo group

Arm A

Active Comparator group

Description:

curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1

Treatment:

Drug: Early postoperative intraperitoneal chemothgerapy

Drug: adjuvant systemic chemotherapy

Procedure: surgery

Arm B

Placebo Comparator group

Description:

curative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1

Treatment:

Drug: adjuvant systemic chemotherapy

Procedure: surgery