Stomach Cancer Clinical Trial
Official title:
A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Gastric Adenocarcinoma: Mitomycin and Doxifluridine Versus Intraperitoneal Chemotherapy and Mitomycin, Doxifluridine, and Cisplatin
NCT number | NCT00296322 |
Other study ID # | AMC0102 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | October 2001 |
Est. completion date | March 2010 |
Verified date | January 2020 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 mitomycin plus doxifluridine in resected advanced gastric cancer.
Status | Completed |
Enrollment | 528 |
Est. completion date | March 2010 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 69 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center | Hallym University Medical Center, Ulsan University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relapse-free Survival | 3 years | ||
Secondary | Toxicity Profile (According to NCI CTC Version 2.0) | Because safety profile in oncology study is evaluated for each toxicity, it is impossible to present the overall patient number. Instead, we presented the number of patients who declined study therapy due to adverse events or patient will. | up to 1 year | |
Secondary | Overall Survival | 3 years |
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