Trial of Adjuvant Chemotherapy for Gastric Cancer

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.

Official Title

A Phase III Randomised Controlled Trial of Adjuvant Chemotherapy for Gastric Adenocarcinoma: Mitomycin and Doxifluridine Versus Intraperitoneal Chemotherapy and Mitomycin, Doxifluridine, and Cisplatin.

Conditions

• Stomach Cancer

Study Type

Interventional

Study Design

Treatment, Randomised, Open Label, Active Control, Parallel Assignment, Efficacy Study.

Further Details

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 randomised 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 the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.

Study Start

October 2001

Eligibility & Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pathologically proven gastric adenocarcinoma
• Grossly serosa invasion of primary tumor is suspicious
• Curative resection was done
• 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
• 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.

Total Enrolment

528

Contact Details

Yoon-Koo Kang, (M.D, Ph.D).
82-2-3010-3230
ykkang@amc.seoul.kr

Location:

Asan Medical Center
Seoul, Korea, Republic of, 138-736