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Status:

UNKNOWN

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

Lead Sponsor:

Fukushima Medical University Hospital

Conditions:

Gastric Cancer

Eligibility:

All Genders

20-75 years

Phase:

PHASE2

Brief Summary

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 ...

Detailed 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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    70 Patients enrolled

    Trial Details

    Trial ID

    NCT00134095

    Start Date

    September 1 2004

    Last Update

    September 17 2013

    Active Locations (7)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    1

    Yamamoto Kumiai General Hospital

    Noshiro, Akita, Japan, 016-0014

    2

    Fukushima Medical University Hospital

    Fukushima, Fukushima, Japan, 960-1295

    3

    Asahikawa Kosei General Hospital

    Asahikawa, Hokkaido, Japan, 078-8211

    4

    Kobe City General Hospital

    Kobe, Hyōgo, Japan, 650