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

Gastric Cancer Clinical Trial

Official title:

Phase III Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Potentially Resectable Stage III Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182611
• Other study ID #: KYUH-UHA-GC04-03
• Secondary ID: CDR0000426403
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2005
• Last updated: June 25, 2013
• Start date: April 2004
• Est. completion date: November 2008

Study information

• Verified date: November 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, 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	Fukui Red Cross Hospital	Fukui
Japan	Shimane Prefectural Central Hospital	Izumo-shi	Shimane
Japan	Kyoto University Hospital	Kyoto
Japan	National Hospital Organization - Kyoto Medical Center	Kyoto
Japan	Kitano Hospital	Osaka
Japan	Yamato Municipal Hospital	Yamatotakada	Nara

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Secondary	Progression-free survival (PFS)			No
Secondary	Postoperative PFS			No
Secondary	Surgical/pathological curative resection			No
Secondary	Death related to treatment			No
Secondary	Death related to operation			No
Secondary	Postoperative complications			No
Secondary	Adverse events			Yes