Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

UNKNOWN

S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer

Lead Sponsor:

Kyoto University

Conditions:

Gastric Cancer

Eligibility:

All Genders

20+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor...

Detailed Description

OBJECTIVES: Primary * Determine the efficacy and feasibility of neoadjuvant chemotherapy comprising S-1 and cisplatin in patients with stage IV gastric adenocarcinoma. * Determine the overall surviv...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed gastric adenocarcinoma
  • Stage IV disease meeting 1 of the following staging criteria according to Japanese gastric cancer classification:
  • T4, N2
  • T4, N3
  • P1, CY1
  • CT scan and laparoscopic staging required
  • PATIENT CHARACTERISTICS:
  • Age
  • 20 and over
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • WBC ≥ 4,000/mm\^3 AND \< 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 ≤ 2.5 times upper limit of normal
  • Bilirubin ≤ 1.5 mg/dL
  • Renal
  • Creatinine clearance ≥ 50 mL/min
  • Pulmonary
  • PaO\_2 ≥ 70 mm Hg on room air
  • Other
  • Able to swallow oral medication
  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT00088816

    Start Date

    April 1 2003

    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

    Kyoto University Hospital

    Kyoto, Kyoto, Japan, 606-8507

    2

    National Hospital Organization - Kyoto Medical Center

    Kyoto, Kyoto, Japan, 612-0861

    3

    Kyoto-Katsura Hospital

    Kyoto, Kyoto, Japan, 615-8256

    4

    Kitano Hospital

    Osaka, Osaka, Japan, 530-8480