Back to resultsS-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
irinotecan hydrochloride
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 adenocarcinoma of the stomach, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer
Eligibility Criteria
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
Sites / Locations
- Yamamoto Kumiai General Hospital
- Asahikawa Kosei General Hospital
- Kobe City General Hospital
- Iwate Medical University Hospital
- Tsuruoka Municipal Shonai Hospital
- Fukushima Medical University Hospital
- Yamagata Prefectural Central Hospital
Outcomes
Primary Outcome Measures
Tumor shrinkage
Historical tumor shrinkage
Overall survival
Progression-free survival
Median survival
Safety
Secondary Outcome Measures
Full Information
NCT ID
NCT00134095
First Posted
August 22, 2005
Last Updated
September 16, 2013
Sponsor
Fukushima Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00134095
Brief Title
S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
Official Title
Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Fukushima Medical University Hospital
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
adenocarcinoma of the stomach, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
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
Tumor shrinkage
Title
Historical tumor shrinkage
Title
Overall survival
Title
Progression-free survival
Title
Median survival
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitsukazu Gotoh, MD
Organizational Affiliation
Fukushima Medical University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Yamamoto Kumiai General Hospital
City
Noshiro
State/Province
Akita
ZIP/Postal Code
016-0014
Country
Japan
Facility Name
Asahikawa Kosei General Hospital
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8211
Country
Japan
Facility Name
Kobe City General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Tsuruoka Municipal Shonai Hospital
City
Tsuruoka
State/Province
Yamagata
ZIP/Postal Code
997-8515
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata
ZIP/Postal Code
990-2292
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
We'll reach out to this number within 24 hrs