A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer
Conditions
Gastric Neoplasm
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Neoadjuvant Therapy, Stomach Neoplasms, Cisplatin, S-1(combination)
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Gastrectomy with more than D2 dissection Type: Procedure
Name: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

1. histologically proven adenocarcinoma of stomach

2. Borrmann type 4 or large (>=8 cm) type 3

3. no evidence of distant metastasis including liver(M0)

4. no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2)

5. no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with laparoscopic confirmation

6. no involvement of the esophagus with > 3cm

7. an age of 20-75 years

8. an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

9. no prior chemotherapy, radiotherapy for any malignancy

10. no prior surgery for gastric cancer except for endoscopic membrane resection (EMR)

11. no breeding from primary tumor or gastrointestinal stenosis

12. sufficient oral intake

13. adequate organ function

14. written informed consent

Exclusion Criteria:

1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ

2. pregnant or breast-feeding women

3. severe mental disease

4. systemic administration of corticosteroids, flucytosine, phenytoin or warfarin

5. other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease

6. myocardial infarction within six disease-free months
Locations
Aichi Cancer Center Hospital
1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan
Status: Recruiting
Contact: Seiji Itoh, M.D. - 81-52-762-6111
Fujita Health University
1-98,Dengakugakubo,Kutsukake-cho,Toyoake, Aichi, Japan
Status: Recruiting
Contact: Ichiro Uyama, M.D.,Ph.D. - 81-562-93-9254
National Cancer Center Hospital East
6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan
Status: Recruiting
Contact: Taira Kinoshita, M.D. - 81-471-33-1111
National Hospital Organization Shikoku Cancer Center
13,Horinouchi,Matsuyama, Ehime, Japan
Status: Recruiting
Contact: Yoshiro Kubo, M.D., Ph.D. - 81-89-932-1111
Gifu Municipal Hospital
7-1,Kashima-cho,Gifu, Gifu, Japan
Status: Recruiting
Contact: Hiroo Ohshita, M.D. - 81-58-251-1101
Hiroshima City Hospital
7-33,Motomachi,Naka-ku,Hiroshima, Hiroshima, Japan
Status: Recruiting
Contact: Masahiko Nishizaki, M.D., Ph.D. - 81-82-221-2291
Itami City Hospital
1-100,Koyaike,Itami, Hyogo, Japan
Status: Recruiting
Contact: Masahiro Hiratsuka, M.D., Ph.D. - 81-72-777-3773
Iwate Medical University
19-1,Uchimaru,Morioka, Iwate, Japan
Status: Recruiting
Contact: Takagane Akinori, M.D., Ph.D. - 81-19-651-5111
Kagoshima University,Faculty of Medicine
8-35-1,Sakuragaoka,Kagoshima, Kagoshima, Japan
Status: Recruiting
Contact: Akihiro Nakajoh, M.D. - 81-99-275-5361
Kanagawa Cancer Center
1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan
Status: Recruiting
Contact: Takaki Yoshikawa, M.D., Ph.D. - 81-45-391-5761
Kyoto Second Red Cross Hospital
355-5,Kamanza-Marutamachi,Kamigyo-ku, Kyoto, Japan
Status: Recruiting
Contact: Masataka Shimotsuma, M.D., Ph.D. - 81-75-231-5171
National Hospital Organization, Sendai Medical Center
2-8-8,Miyagino,Miyagino-ku,Sendai, Miyagi, Japan
Status: Recruiting
Contact: Shin Teshima, M.D. - 81-22-293-1111
Miyagi Cancer Center
47-1,Nodayama,Medeshima-Shiode,Natori, Miyagi, Japan
Status: Recruiting
Contact: Hideaki Yamanami, M.D.,Ph.D. - 81-22-384-3151
Niigata Cancer Center Hospital
2-15-3,Kawagishi-cho,Niigata, Niigata, Japan
Status: Recruiting
Contact: Hiroshi Yabusaki, M.D. - 81-25-266-5111
Nagaoka Chuo General Hospital
2041,Kawasaki,Nagaoka, Niigata, Japan
Status: Recruiting
Contact: Yasuyuki Kawachi, M.D. - 81-258-35-3700
Tsubame Rosai Hospital
633,Sawatari,Tsubame, Niigata, Japan
Status: Recruiting
Contact: Kikuo Aizawa, M.D. - 81-256-64-5111
Oita University Fuculty of Medicine
1-1,Oogaoka,Hasama-machi,Oita, Oita, Japan
Status: Recruiting
Contact: Norio Shiraishi, M.D. - 81-97-586-5843
Sakai Municipal Hospital
1-1-1,Minamiyasuicho,Sakai, Osaka, Japan
Status: Recruiting
Contact: Hiroshi Imamura, M.D., Ph.D. - 81-72-221-1700
Osaka Medical Center for Cancer and Cardiovascular Diseases
1-3-3,Nakamichi,Higashinari-ku,Osaka, Osaka, Japan
Status: Recruiting
Contact: Isao Miyashiro, M.D., Ph.D. - 81-6-6972-1181
Osaka National Hospital
2-1-14,Hoenzaka,Chuo-ku,Osaka, Osaka, Japan
Status: Recruiting
Contact: Motohiro Hirao, M.D. - 81-6-6942-1331
Osaka Medical College
2-7,Daigakucho,Takatsuki, Osaka, Japan
Status: Recruiting
Contact: Eiji Nomura, M.D. - 81-72-683-1221
Kinki University School of Medicine
377-2,Ohno-higashi,Osaka-Sayama, Osaka, Japan
Status: Recruiting
Contact: Hironori Shigeoka, M.D., Ph.D. - 81-72-366-0221
Toyonaka Municipal Hospital
4-14-1,Shibaharacho,Toyonaka, Osaka, Japan
Status: Recruiting
Contact: Junya Fujita, M.D. - 81-6-6843-0101
National Defense Medical College
3-2,Namiki,Tokorozawa, Saitama, Japan
Status: Recruiting
Contact: Takashi Ichikura, M.D. - 81-4-2995-1637
Saitama Cancer Center
818,Komuro,Ina,Kita-adachi, Saitama, Japan
Status: Recruiting
Contact: Yoshiyuki Kawashima, M.D. - 81-48-722-1111
Shizuoka General Hospital
4-27-1,Kitaando,Aoi-ku,Shizuoka, Sizuoka, Japan
Status: Recruiting
Contact: Masakazu Takagi, M.D. - 81-54-247-6111
International Medical Center of Japan
1-21-1,Toyama,Shinjuku-ku, Tokyo, Japan
Status: Recruiting
Contact: Toshio Shimizu, M.D. - 81-3-3202-7181
Tokyo Medical and Dental University Hospital
1-5-45,Yushima,Bunkyo-ku, Tokyo, Japan
Status: Recruiting
Contact: Kazuyuki Kojima, M.D. - 81-3-5803-5261
Cancer Institute Hospital
3-10-6,Ariake,Koto-ku, Tokyo, Japan
Status: Recruiting
Contact: Yasuyuki Seto, M.D., Ph.D. - 81-3-3520-0111
Tokyo Metropolitan Komagome Hospital
3-18-22,Honkomagome,Bunkyo-ku, Tokyo, Japan
Status: Recruiting
Contact: Yoshiaki Iwasaki, M.D. - 81-3-3823-2101
Tokyo Metropolitan Bokutoh Hospital
4-23-15,Koutoubashi,Sumida-ku, Tokyo, Japan
Status: Recruiting
Contact: Satoru Inoue, M.D. - 81-3-3633-6151
National Cancer Center Hospital
5-1-1,Tsukiji,Chuo-ku, Tokyo, Japan
Status: Recruiting
Contact: Takeshi Sano - 81-3-3542-2511
Toyama Prefectural Central Hospital
2-2-78,nishinagae,Toyama, Toyama, Japan
Status: Recruiting
Contact: Masahide Kaji, M.D., Ph.D. - 81-76-424-1531
Wakayama Medical University, School of Medicine
811-1,Kimiidera,Wakayama, Wakayama, Japan
Status: Recruiting
Contact: Makoto Iwahashi, M.D., Ph.D. - 81-73-441-0612
Yamagata Prefectural Central Hospital
1800,Aoyagi,Yamagata, Yamagata, Japan
Status: Recruiting
Contact: Norimasa Fukushima, M.D. - 81-23-685-2626
Start Date
November 2005
Completion Date
April 2015
Sponsors
Japan Clinical Oncology Group
Source
Japan Clinical Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page