Clinical trial NCT02205008: Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer
Official title: Prospective Randomized Multicenter Phase III Trial of Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Advanced Gastric Cancer With Serosal Invasion
Keywords: advanced gastric cancer
serosal invasion
peritoneal recurrence
intraperitoneal chemotherapy
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Center, Korea
name: Keimyung University Dongsan Medical Center
name: Yeungnam University Hospital
name: Daegu Catholic University Medical Center
name: Chonnam National University Hospital
name: Dong-A University Hospital
name: Severance Hospital
name: Korea Cancer Center Hospital
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Hanyang University
First posted: 2014-07-31
Enrollment: 230
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: relapsed free survival
timeFrame: postoperative 3 years
Secondary outcomes:
measure: overall survival
timeFrame: postoperative 5 years
Other outcomes:
measure: surgery and intraperitoneal chemotherapy-related morbidity and mortality
timeFrame: postoperative 30days
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center Gastric Cancer Center
Study officials:
affiliation: Kyungpook National University Medical Center
name: Wansik Yu, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
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