Advanced Gastric Cancer With Serosal Invasion Clinical Trial
— EPIC-GCOfficial title:
Prospective Randomized Multicenter Phase III Trial of Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer
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.
| Status | Recruiting |
| Enrollment | 230 |
| Est. completion date | November 2018 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Kyungpook National University Medical Center Gastric Cancer Center | Daegu |
| Lead Sponsor | Collaborator |
|---|---|
| Kyungpook National University | Chonnam National University Hospital, Chung-Ang University Hospital, 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 |
Korea, Republic of,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | surgery and intraperitoneal chemotherapy-related morbidity and mortality | In hospital complication related to surgery or intraperitoneal chemotherapy will be recored and analyzed to evaluate the safety of intraperitoneal chemotherapy. | postoperative 30days | Yes |
| Primary | relapsed free survival | during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded | postoperative 3 years | No |
| Secondary | overall survival | during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded | postoperative 5 years | No |