Trial of Adjuvant Chemotherapy for Gastric Cancer

Study Overview
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Brief Summary
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This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.

Detailed Description
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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.

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

Conditions
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Stomach Cancer

Intervention / Treatment
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* Drug: Mitomycin, doxifluridine and cisplatin
* Drug: Mitomycin and doxifluridine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mitomycin and doxifluridine<br>Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84) | Drug: Mitomycin and doxifluridine<br>* Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)<br>|
| Experimental: Mitomycin, doxifluridine and cisplatin<br>Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168) | Drug: Mitomycin, doxifluridine and cisplatin<br>* Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free Survival Rate | Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery. Relapse was defined as any new tumor lesion. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival Rate | Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery. | 3 years | 
| Number of Patients With Adverse Events | Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach cancer, Adjuvant chemotherapy, Mitomycin, Cisplatin, Doxifluridine