S-1 and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage III Stomach Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00182611
First received: September 15, 2005
Last updated: June 25, 2013
Last verified: November 2008
  Purpose

RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, 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 removed. It is not yet known whether giving S-1 together with cisplatin before surgery is more effective than surgery followed by S-1 in treating stomach cancer.

PURPOSE: This randomized phase III trial is studying how well giving S-1 together with cisplatin before surgery works compared to surgery followed by S-1 in treating patients with stage III stomach cancer.


Condition Intervention Phase
Gastric Cancer
Drug: cisplatin
Drug: tegafur-gimeracil-oteracil potassium
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Potentially Resectable Stage III 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:
  • Progression-free survival (PFS) [ Designated as safety issue: No ]
  • Postoperative PFS [ Designated as safety issue: No ]
  • Surgical/pathological curative resection [ Designated as safety issue: No ]
  • Death related to treatment [ Designated as safety issue: No ]
  • Death related to operation [ Designated as safety issue: No ]
  • Postoperative complications [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2004
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Compare the overall survival of patients with potentially resectable stage III gastric cancer treated with neoadjuvant S-1 and cisplatin followed by gastrectomy and adjuvant S-1 vs no neoadjuvant chemotherapy before gastrectomy and adjuvant S-1.

Secondary

  • Compare the progression-free survival of patients treated with these regimens.
  • Compare the curative resection rates in patients treated with these regimens.
  • Compare the safety of these regimens, in terms of postoperative complications, adverse events, and treatment- or surgery-related mortality rate, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T3 vs T4) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (control): Patients undergo gastrectomy with D2+ lymph node dissection. Patients then receive adjuvant oral S-1.
  • Arm II (neoadjuvant therapy): Patients receive neoadjuvant 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. Patients then undergo surgery and receive adjuvant S-1 as in arm I.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) 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, including type II or type III adenocarcinoma of the esophagogastric junction

    • Stage III disease

      • T3 or T4 and/or N2

        • No stage IV disease
    • Helical CT scan and laparoscopic staging required
  • Potentially resectable disease

PATIENT CHARACTERISTICS:

Age

  • 20 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 4,000/mm³, but < 12,000/mm³
  • Granulocyte count ≥ 2,000/mm³
  • Platelet count ≥ 100,000/mm³
  • 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

  • Arterial oxygen pressure (PaO_2) ≥ 70 mm Hg on room air

Other

  • Able to take oral medications

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: NCT00182611

Locations
Japan
Yamato Municipal Hospital
Yamatotakada, Nara, Japan, 635-8501
Shimane Prefectural Central Hospital
Izumo-shi, Shimane, Japan, 693-0068
Fukui Red Cross Hospital
Fukui, Japan, 918-8501
National Hospital Organization - Kyoto Medical Center
Kyoto, Japan, 612-0861
Kyoto University Hospital
Kyoto, Japan, 606-8507
Kitano Hospital
Osaka, Japan, 530-8480
Sponsors and Collaborators
Kyoto University
Investigators
Study Chair: Seiji Satoh Kyoto University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00182611     History of Changes
Other Study ID Numbers: KYUH-UHA-GC04-03, CDR0000426403
Study First Received: September 15, 2005
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III 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 August 01, 2014