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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00088816
First received: August 4, 2004
Last updated: September 16, 2013
Last verified: March 2008
  Purpose

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 Intervention Phase
Gastric Cancer
Drug: cisplatin
Drug: tegafur-gimeracil-oteracil potassium
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Tumor response [ Designated as safety issue: No ]
  • Death related to treatment [ Designated as safety issue: No ]
  • Histological response [ Designated as safety issue: No ]
  • Postoperative complications [ Designated as safety issue: No ]
  • Surgical/pathological curative resection [ Designated as safety issue: No ]
  • Types of initial recurrence [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: April 2003
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088816

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00088816     History of Changes
Other Study ID Numbers: CDR0000368443, KYUH-UHA-GC03-01
Study First Received: August 4, 2004
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 15, 2014