Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 22, 2005
Last updated: September 16, 2013
Last verified: January 2010

August 22, 2005
September 16, 2013
September 2004
August 2008   (final data collection date for primary outcome measure)
  • Tumor shrinkage [ Designated as safety issue: No ]
  • Historical tumor shrinkage [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Median survival [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00134095 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer

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.



  • Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer.


  • 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.

Phase 2
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • Drug: irinotecan hydrochloride
  • Drug: tegafur-gimeracil-oteracil potassium
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Not Provided
August 2008   (final data collection date for primary outcome measure)


  • 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



  • 20 to 75

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • WBC 4,000-12,000/mm^3
  • Granulocyte count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL


  • AST and ALT ≤ 100 U/L
  • Bilirubin ≤ 1.5 mg/dL


  • Creatinine normal OR
  • Creatinine clearance ≥ 50 mL/min


  • PaO_2 > 60 mm Hg on room air


  • Able to swallow oral medication


Biologic therapy

  • No prior biologic therapy for gastric cancer


  • No prior chemotherapy for gastric cancer

Endocrine therapy

  • No prior endocrine therapy for gastric cancer


  • No prior radiotherapy for gastric cancer


  • No prior surgery for gastric cancer


  • No other prior therapy for gastric cancer
20 Years to 75 Years
Contact information is only displayed when the study is recruiting subjects
CDR0000439474, FMUH-UHA-GC04-02
Not Provided
Not Provided
Fukushima Medical University Hospital
Not Provided
Study Chair: Mitsukazu Gotoh, MD Fukushima Medical University Hospital
National Cancer Institute (NCI)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP