A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma
18 Years
69 Years
Both
Stomach Cancer
Trial Information
A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma
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. However, a substantial number of patients eventually die of recurrences after
curative resection. A number of randomized trials investigating the role of adjuvant
chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still
controversial and varied between Western and Asian trials. Meta-analysis of Western trials
didn't demonstrate the benefit of adjuvant chemotherapy after curative resection.
Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after
curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in
resected gastric cancer compared to no treatment.
This study is designed to evaluate the efficacy of mitomycin, cisplatin and prolonged
treatment with doxifluridine compared to mitomycin plus doxifluridine.
Inclusion Criteria:
- 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 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 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Relapse free survival
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Yoon-Koo Kang, M.D.,Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Asan Medical Center
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
AMC-ONCGI-0204
NCT ID:
NCT00296335
Start Date:
February 2002
Completion Date:
December 2009
Related Keywords:
- Stomach Cancer
- Stomach cancer
- Adjuvant chemotherapy
- Mitomycin
- Cisplatin
- Doxifluridine
- Stomach Neoplasms
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