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A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma

Phase 3
18 Years
69 Years
Not Enrolling
Stomach Cancer

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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

- 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

- 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:


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:


Principal Investigator

Yoon-Koo Kang, M.D.,Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

February 2002

Completion Date:

December 2009

Related Keywords:

  • Stomach Cancer
  • Stomach cancer
  • Adjuvant chemotherapy
  • Mitomycin
  • Cisplatin
  • Doxifluridine
  • Stomach Neoplasms