This trial is active, not recruiting.

Condition gastric cancer
Treatments irinotecan hydrochloride, tegafur-gimeracil-oteracil potassium, adjuvant therapy, conventional surgery, neoadjuvant therapy
Phase phase 2
Sponsor Fukushima Medical University Hospital
Start date September 2004
End date August 2008
Trial size 70 participants
Trial identifier NCT00134095, CDR0000439474, FMUH-UHA-GC04-02


RATIONALE: Drugs used in chemotherapy, such as S-1 and irinotecan, 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 completely removed.

PURPOSE: This phase II trial is studying how well giving S-1 together with irinotecan works in treating patients who are undergoing surgery for locally advanced stomach cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Tumor shrinkage
time frame:
Historical tumor shrinkage
time frame:
Overall survival
time frame:
Progression-free survival
time frame:
Median survival
time frame:
time frame:

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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

Additional Information

Official title Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).