Back to resultsS-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
cisplatin
tegafur-gimeracil-oteracil potassium
adjuvant therapy
conventional surgery
neoadjuvant therapy
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring stage IV gastric cancer, adenocarcinoma of the stomach
Eligibility 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
Sites / Locations
- Shimane Prefectural Central Hospital
- Kyoto University Hospital
- National Hospital Organization - Kyoto Medical Center
- Kyoto-Katsura Hospital
- Kitano Hospital
- Kansai Denryoku Hospital
- Yamato Municipal Hospital
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Time to progression
Tumor response
Death related to treatment
Histological response
Postoperative complications
Surgical/pathological curative resection
Types of initial recurrence
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00088816
Brief Title
S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer
Official Title
Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2003 (undefined)
Primary Completion Date
March 2008 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Kyoto University
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
stage IV gastric cancer, adenocarcinoma of the stomach
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
tegafur-gimeracil-oteracil potassium
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Primary Outcome Measure Information:
Title
Overall survival
Secondary Outcome Measure Information:
Title
Time to progression
Title
Tumor response
Title
Death related to treatment
Title
Histological response
Title
Postoperative complications
Title
Surgical/pathological curative resection
Title
Types of initial recurrence
Title
Adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seiji Satoh
Organizational Affiliation
Kyoto University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shimane Prefectural Central Hospital
City
Izumo-shi
State/Province
Shimane
ZIP/Postal Code
693-0068
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
National Hospital Organization - Kyoto Medical Center
City
Kyoto
ZIP/Postal Code
612-0861
Country
Japan
Facility Name
Kyoto-Katsura Hospital
City
Kyoto
ZIP/Postal Code
615-8256
Country
Japan
Facility Name
Kitano Hospital
City
Osaka
ZIP/Postal Code
530-8480
Country
Japan
Facility Name
Kansai Denryoku Hospital
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
Yamato Municipal Hospital
City
Yamato City Kanagawa
ZIP/Postal Code
242-8602
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21667134
Citation
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 cancer. Gastric Cancer. 2012 Jan;15(1):61-9. doi: 10.1007/s10120-011-0066-9. Epub 2011 Jun 11.
Results Reference
result
Learn more about this trial
S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer
We'll reach out to this number within 24 hrs