Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer
Data Collection
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Treatment Study
Summary
Study start date: April 1, 2003
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the efficacy and feasibility of neoadjuvant chemotherapy comprising S-1 and cisplatin in patients with stage IV gastric adenocarcinoma. * Determine the overall survival of patients treated with this regimen. Secondary * Determine the time to progression and types of initial recurrence in patients treated with this regimen. * Determine tumor response in patients treated with this regimen. * Determine mortality and morbidity related to treatment in these patients. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral S-1 on days 1-21 and cisplatin IV over 2 hours on day 8. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. Patients resume oral S-1 after surgery. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed gastric adenocarcinoma * Stage IV disease meeting 1 of the following staging criteria according to Japanese gastric cancer classification: * T4, N2 * T4, N3 * P1, CY1 * CT scan and laparoscopic staging required PATIENT CHARACTERISTICS: Age * 20 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * WBC ≥ 4,000/mm\^3 AND \< 12,000/mm\^3 * Granulocyte count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL Hepatic * AST and ALT ≤ 2.5 times upper limit of normal * Bilirubin ≤ 1.5 mg/dL Renal * Creatinine clearance ≥ 50 mL/min Pulmonary * PaO_2 ≥ 70 mm Hg on room air Other * Able to swallow oral medication PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for gastric cancer Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for gastric cancer Surgery * No prior surgery for gastric cancer Other * No other prior therapy for gastric cancer
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Kyoto University Hospital
Kyoto, JapanNational Hospital Organization - Kyoto Medical Center
Kyoto, JapanKyoto-Katsura Hospital
Kyoto, Japan