A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer
- Conditions
- Gastric Neoplasm
- Interventions
- Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomyProcedure: Gastrectomy with more than D2 dissection
- Registration Number
- NCT00252161
- Lead Sponsor
- Haruhiko Fukuda
- 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 tumor in comparison with surgery alone.
- 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 of 300 patients will be accrued for this study from 35 institutions within five years. The primary endpoint is overall survival. The secondary endpoints are progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 316
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy 1 Gastrectomy with more than D2 dissection Procedure/Surgery: Gastrectomy with more than D2 dissection
- Primary Outcome Measures
Name Time Method overall survival during the study conduct
- Secondary Outcome Measures
Name Time Method progression free survival (PFS) during the study conduct response rate during the study conduct adverse events during the study conduct proportion of protocol achievement during the study conduct proportion of curative resection during the study conduct
Trial Locations
- Locations (35)
Aichi Cancer Center Hospital
🇯🇵Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan
Itami City Hospital
🇯🇵Itami,Koyaike,1-100, Hyogo, Japan
Miyagi Cancer Center
🇯🇵Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan
Osaka Medical College
🇯🇵Takatsuki,Daigakucho,2-7, Osaka, Japan
Fujita Health University
🇯🇵Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan
Tsubame Rosai Hospital
🇯🇵Tsubame,Sawatari,633, Niigata, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
🇯🇵Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan
Sakai Municipal Hospital
🇯🇵Sakai,Minamiyasuicho,1-1-1, Osaka, Japan
Gifu Municipal Hospital
🇯🇵Gifu,Kashima-cho,7-1, Gifu, Japan
Hiroshima City Hospital
🇯🇵Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan
National Hospital Organization, Sendai Medical Center
🇯🇵Sendai,Miyagino-ku,Miyagino,2-8-8, Miyagi, Japan
Tokyo Metropolitan Komagome Hospital
🇯🇵Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan
Tokyo Medical and Dental University Hospital
🇯🇵Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan
Wakayama Medical University, School of Medicine
🇯🇵Wakayama,Kimiidera,811-1, Wakayama, Japan
Tokyo Metropolitan Bokutoh Hospital
🇯🇵Sumida-ku,Koutoubashi,4-23-15, Tokyo, Japan
Nagaoka Chuo General Hospital
🇯🇵Nagaoka,Kawasaki,2041, Niigata, Japan
Kanagawa Cancer Center
🇯🇵Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama,Horinouchi,13, Ehime, Japan
Iwate Medical University
🇯🇵Morioka,Uchimaru,19-1, Iwate, Japan
Kagoshima University,Faculty of Medicine
🇯🇵Kagoshima,Sakuragaoka,8-35-1, Kagoshima, Japan
Kyoto Second Red Cross Hospital
🇯🇵Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, Japan
Osaka National Hospital
🇯🇵Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan
International Medical Center of Japan
🇯🇵Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan
Oita University Fuculty of Medicine
🇯🇵Oita,Hasama-machi,Oogaoka,1-1, Oita, Japan
Kinki University School of Medicine
🇯🇵Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan
Toyonaka Municipal Hospital
🇯🇵Toyonaka,Shibaharacho,4-14-1, Osaka, Japan
Saitama Cancer Center
🇯🇵Kita-adachi,Ina,Komuro,818, Saitama, Japan
National Defense Medical College
🇯🇵Tokorozawa,Namiki,3-2, Saitama, Japan
Shizuoka General Hospital
🇯🇵Shizuoka,Aoi-ku,Kitaando,4-27-1, Sizuoka, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
Cancer Institute Hospital
🇯🇵Koto-ku,Ariake,3-10-6, Tokyo, Japan
Toyama Prefectural Central Hospital
🇯🇵Toyama,nishinagae,2-2-78, Toyama, Japan
Yamagata Prefectural Central Hospital
🇯🇵Yamagata,Aoyagi,1800, Yamagata, Japan