Status:
COMPLETED
A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer
Lead Sponsor:
Haruhiko Fukuda
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Gastric Neoplasm
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tum...
Detailed Description
A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3 gastric cancer.A total...
Eligibility Criteria
Inclusion
- histologically proven adenocarcinoma of stomach
- Borrmann type 4 or large (\>=8 cm) type 3
- no evidence of distant metastasis including liver(M0)
- no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2)
- no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with laparoscopic confirmation
- no involvement of the esophagus with \> 3cm
- an age of 20-75 years
- an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- no prior chemotherapy, radiotherapy for any malignancy
- no prior surgery for gastric cancer except for endoscopic membrane resection (EMR)
- no breeding from primary tumor or gastrointestinal stenosis
- sufficient oral intake
- adequate organ function
- written informed consent
Exclusion
- synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- pregnant or breast-feeding women
- severe mental disease
- systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
- other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
- myocardial infarction within six disease-free months
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT00252161
Start Date
November 1 2005
End Date
April 1 2015
Last Update
September 22 2016
Active Locations (35)
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1
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan, 464-8681
2
Fujita Health University
Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, Japan, 470-1192
3
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
4
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007