Advanced Gastric Cancer With Serosal Invasion
Conditions
Keywords
advanced gastric cancer, serosal invasion, peritoneal recurrence, intraperitoneal chemotherapy
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.
Interventions
PROCEDUREsurgery
Total or subtotal gastrectomy with D2
adjuvant systemic chemotherapy with S-1 (\<1.25m2:40mg, 1.25-1.5m2:50mg, \>1.5m2:60mg, bid)
DRUGEarly postoperative intraperitoneal chemothgerapy
operation day: 0.9％ saline solution 1L plus mitomycin C 10 mg/m2 1 - 4 postoprative day: 0.9％ saline solution 1L plus 5-FU 700 mg/m2 plus sodium bicarbonate 50 mEq
Sponsors
National Cancer Center, Korea
Keimyung University Dongsan Medical Center
Yeungnam University Hospital
Daegu Catholic University Medical Center
Chonnam National University Hospital
Dong-A University Hospital
Severance Hospital
Korea Cancer Center Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Hanyang University
Kyungpook National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| overall survival | postoperative 5 years | during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded |
Other
| Measure | Time frame | Description |
|---|---|---|
| surgery and intraperitoneal chemotherapy-related morbidity and mortality | postoperative 30days | In hospital complication related to surgery or intraperitoneal chemotherapy will be recored and analyzed to evaluate the safety of intraperitoneal chemotherapy. |
Countries
South Korea
Contacts
Primary ContactWansik Yu, MD, PhD, FACS
Outcome results
None listed