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

September 16, 2013 updated by: Fukushima Medical University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital
      • Yamagata, Japan, 990-2292
        • Yamagata Prefectural Central Hospital
    • Akita
      • Noshiro, Akita, Japan, 016-0014
        • Yamamoto Kumiai General Hospital
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8211
        • Asahikawa Kosei General Hospital
    • Hyogo
      • Kobe, Hyogo, Japan, 650
        • Kobe City General Hospital
    • Iwate
      • Morioka, Iwate, Japan, 020-8505
        • Iwate Medical University Hospital
    • Yamagata
      • Tsuruoka, Yamagata, Japan, 997-8515
        • Tsuruoka Municipal Shonai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival
Overall survival
Safety
Median survival
Tumor shrinkage
Historical tumor shrinkage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fukushima Medical University Hospital

Investigators

  • Study Chair: Mitsukazu Gotoh, MD, Fukushima Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 22, 2005

First Posted (ESTIMATE)

August 24, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000439474
  • FMUH-UHA-GC04-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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