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 is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.
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
- 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: ECOG 0-2
- Adequate bone marrow function (WBC ≥ 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, AST/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 CT
- Systemic disease which interfere the administration of chemotherapy
- Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
855 Patients enrolled
Trial Details
Trial ID
NCT00296335
Start Date
February 1 2002
End Date
December 1 2009
Last Update
February 27 2014
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736