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

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ClinicalTrials.gov Identifier: NCT00088816
Recruitment Status : Unknown
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 5, 2004
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:

Study Description
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 cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works in treating patients who are undergoing surgery for stage IV gastric cancer.


Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: cisplatin Drug: tegafur-gimeracil-oteracil potassium Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

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 survival of patients treated with this regimen.

Secondary

  • Determine the time to progression and types of initial recurrence in patients treated with this regimen.
  • Determine tumor response in patients treated with this regimen.
  • Determine mortality and morbidity related to treatment in these patients.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral S-1 on days 1-21 and cisplatin IV over 2 hours on day 8. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. Patients resume oral S-1 after surgery.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer
Study Start Date : April 2003
Estimated Primary Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Time to progression
  2. Tumor response
  3. Death related to treatment
  4. Histological response
  5. Postoperative complications
  6. Surgical/pathological curative resection
  7. Types of initial recurrence
  8. Adverse events

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088816


Locations
Japan
Shimane Prefectural Central Hospital
Izumo-shi, Shimane, Japan, 693-0068
Kyoto University Hospital
Kyoto, Japan, 606-8507
National Hospital Organization - Kyoto Medical Center
Kyoto, Japan, 612-0861
Kyoto-Katsura Hospital
Kyoto, Japan, 615-8256
Kitano Hospital
Osaka, Japan, 530-8480
Kansai Denryoku Hospital
Osaka, Japan, 553-0003
Yamato Municipal Hospital
Yamato City Kanagawa, Japan, 242-8602
Sponsors and Collaborators
Kyoto University
Investigators
Study Chair: Seiji Satoh Kyoto University
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00088816     History of Changes
Other Study ID Numbers: CDR0000368443
KYUH-UHA-GC03-01
First Posted: August 5, 2004    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: March 2008

Keywords provided by National Cancer Institute (NCI):
stage IV gastric cancer
adenocarcinoma of the stomach

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Tegafur
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action