Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer
20 Years
75 Years
Both
Gastric Cancer
Trial Information
Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer
OBJECTIVES:
Primary
- Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally
advanced gastric cancer.
Secondary
- Determine the histological response in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine postoperative morbidity in patients treated with this regimen.
- Determine the rate of potentially curative surgery in patients treated with this
regimen.
OUTLINE: This is a multicenter study.
Patients receive oral S-1 on days 1-21 and irinotecan IV over 90 minutes on days 1 and 15.
Treatment repeats every 28 days for 2 courses in the absence of disease progression or
unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. After
surgery, patients resume treatment with S-1 alone as before for 1 year.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed gastric adenocarcinoma
- Locally advanced disease
- Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer
classification)
- Planning to undergo curative surgery after neoadjuvant chemotherapy
PATIENT CHARACTERISTICS:
Age
- 20 to 75
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC 4,000-12,000/mm^3
- Granulocyte count ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
Hepatic
- AST and ALT ≤ 100 U/L
- Bilirubin ≤ 1.5 mg/dL
Renal
- Creatinine normal OR
- Creatinine clearance ≥ 50 mL/min
Pulmonary
- PaO_2 > 60 mm Hg on room air
Other
- Able to swallow oral medication
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy for gastric cancer
Chemotherapy
- No prior chemotherapy for gastric cancer
Endocrine therapy
- No prior endocrine therapy for gastric cancer
Radiotherapy
- No prior radiotherapy for gastric cancer
Surgery
- No prior surgery for gastric cancer
Other
- No other prior therapy for gastric cancer
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor shrinkage
Safety Issue:
No
Principal Investigator
Mitsukazu Gotoh, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fukushima Medical University Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000439474
NCT ID:
NCT00134095
Start Date:
September 2004
Completion Date:
Related Keywords:
- Gastric Cancer
- adenocarcinoma of the stomach
- stage II gastric cancer
- stage III gastric cancer
- stage IV gastric cancer
- Stomach Neoplasms
Name | Location |
|---|
