Gastric Cancer
Conditions
Keywords
stage III gastric cancer, adenocarcinoma of the stomach
Brief summary
RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether giving S-1 together with cisplatin before surgery is more effective than surgery followed by S-1 in treating stomach cancer. PURPOSE: This randomized phase III trial is studying how well giving S-1 together with cisplatin before surgery works compared to surgery followed by S-1 in treating patients with stage III stomach cancer.
Detailed description
OBJECTIVES: Primary * Compare the overall survival of patients with potentially resectable stage III gastric cancer treated with neoadjuvant S-1 and cisplatin followed by gastrectomy and adjuvant S-1 vs no neoadjuvant chemotherapy before gastrectomy and adjuvant S-1. Secondary * Compare the progression-free survival of patients treated with these regimens. * Compare the curative resection rates in patients treated with these regimens. * Compare the safety of these regimens, in terms of postoperative complications, adverse events, and treatment- or surgery-related mortality rate, in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T3 vs T4) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms. * Arm I (control): Patients undergo gastrectomy with D2+ lymph node dissection. Patients then receive adjuvant oral S-1. * Arm II (neoadjuvant therapy): Patients receive neoadjuvant 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. Patients then undergo surgery and receive adjuvant S-1 as in arm I. PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Interventions
DRUGcisplatin
PROCEDUREadjuvant therapy
PROCEDUREconventional surgery
PROCEDUREneoadjuvant therapy
Sponsors
Kyoto University
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed gastric adenocarcinoma, including type II or type III adenocarcinoma of the esophagogastric junction * Stage III disease * T3 or T4 and/or N2 * No stage IV disease * Helical CT scan and laparoscopic staging required * Potentially resectable disease PATIENT CHARACTERISTICS: Age * 20 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * WBC ≥ 4,000/mm³, but \< 12,000/mm³ * Granulocyte count ≥ 2,000/mm³ * Platelet count ≥ 100,000/mm³ * 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 * Arterial oxygen pressure (PaO\_2) ≥ 70 mm Hg on room air Other * Able to take oral medications 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative PFS | — |
| Surgical/pathological curative resection | — |
| Death related to treatment | — |
| Progression-free survival (PFS) | — |
| Postoperative complications | — |
| Adverse events | — |
| Death related to operation | — |
Countries
Japan
Outcome results
None listed