Status:
COMPLETED
Trial of Adjuvant Chemotherapy for Gastric Cancer
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Ulsan University Hospital
Hallym University Medical Center
Conditions:
Stomach Cancer
Eligibility:
All Genders
18-69 years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitom...
Detailed Description
Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. Howev...
Eligibility Criteria
Inclusion
- Pathologically proven gastric adenocarcinoma
- Grossly serosa invasion of primary tumor is suspicious
- Curative resection was done
- Stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node metastasis)
- Age: 18-69 years old
- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2
- Adequate bone marrow function (white blood cell counts ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 10 g/dl)
- Adequate renal function (serum creatinine≤ 1.5)
- Adequate liver function (serum bilirubin ≤1.5 mg/dl, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x normal upper limit)
- Written informed consent was signed by the patient
Exclusion
- Previous chemotherapy or radiotherapy
- Active ongoing infection which antibiotic treatment is needed
- Pregnant or lactating women
- Psychosis or convulsion disorder
- Ascites in preoperative abdomen computed tomography (CT)
- Systemic disease which interfere the administration of chemotherapy
- Postoperative pathologic stage IA, IB
- Postoperative pathology indicates that resection margin is involved
- Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT00296322
Start Date
October 1 2001
End Date
March 1 2010
Last Update
January 18 2020
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736