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

Gastric Cancer Clinical Trial

Official title:

Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00088816
• Other study ID #: CDR0000368443
• Secondary ID: KYUH-UHA-GC03-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 4, 2004
• Last updated: September 16, 2013
• Start date: April 2003

Study information

• Verified date: March 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• cisplatin

• tegafur-gimeracil-oteracil potassium

Procedure:
• adjuvant therapy

• conventional surgery

• neoadjuvant therapy

Locations

Country	Name	City	State
Japan	Shimane Prefectural Central Hospital	Izumo-shi	Shimane
Japan	Kyoto University Hospital	Kyoto
Japan	Kyoto-Katsura Hospital	Kyoto
Japan	National Hospital Organization - Kyoto Medical Center	Kyoto
Japan	Kansai Denryoku Hospital	Osaka
Japan	Kitano Hospital	Osaka
Japan	Yamato Municipal Hospital	Yamato City Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Satoh S, Okabe H, Teramukai S, Hasegawa S, Ozaki N, Ueda S, Tsuji A, Sakabayashi S, Fukushima M, Sakai Y. Phase II trial of combined treatment consisting of preoperative S-1 plus cisplatin followed by gastrectomy and postoperative S-1 for stage IV gastric — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Secondary	Time to progression			No
Secondary	Tumor response			No
Secondary	Death related to treatment			No
Secondary	Histological response			No
Secondary	Postoperative complications			No
Secondary	Surgical/pathological curative resection			No
Secondary	Types of initial recurrence			No
Secondary	Adverse events			Yes