A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer

NCT ID: NCT00252161

Last Updated: 2016-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2015-04-30

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.

Conditions

Gastric Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy

Group Type: EXPERIMENTAL

Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy

Intervention Type: DRUG

Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy

1

Procedure/Surgery: Gastrectomy with more than D2 dissection

Group Type: ACTIVE_COMPARATOR

Gastrectomy with more than D2 dissection

Intervention Type: PROCEDURE

Gastrectomy with more than D2 dissection

Interventions

Gastrectomy with more than D2 dissection

Gastrectomy with more than D2 dissection

Intervention Type: PROCEDURE

Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy

Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role: collaborator

Haruhiko Fukuda

OTHER

Sponsor Role: lead

Responsible Party

Haruhiko Fukuda

JCOG Data Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mitsuru Sasako, MD, PhD

Role: STUDY_CHAIR

Hyogo Medical University

Locations

Aichi Cancer Center Hospital

Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan

Fujita Health University

Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, Japan

Gifu Municipal Hospital

Gifu,Kashima-cho,7-1, Gifu, Japan

Hiroshima City Hospital

Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan

Itami City Hospital

Itami,Koyaike,1-100, Hyōgo, Japan

Iwate Medical University

Morioka,Uchimaru,19-1, Iwate, Japan

Kagoshima University,Faculty of Medicine

Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, Japan

Kanagawa Cancer Center

Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan

Kyoto Second Red Cross Hospital

Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, Japan

Miyagi Cancer Center

Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan

National Hospital Organization, Sendai Medical Center

Sendai,Miyagino-ku,Miyagino,2-8-8, Miyagi, Japan

Nagaoka Chuo General Hospital

Nagaoka,Kawasaki,2041, Niigata, Japan

Niigata Cancer Center Hospital

Niigata,Kawagishi-cho,2-15-3, Niigata, Japan

Tsubame Rosai Hospital

Tsubame,Sawatari,633, Niigata, Japan

Oita University Fuculty of Medicine

Oita,Hasama-machi,Oogaoka,1-1, Oita Prefecture, Japan

Osaka National Hospital

Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan

Kinki University School of Medicine

Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan

Sakai Municipal Hospital

Sakai,Minamiyasuicho,1-1-1, Osaka, Japan

Osaka Medical College

Takatsuki,Daigakucho,2-7, 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, Shizuoka, 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

National Cancer Center Hospital

Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan

Cancer Institute Hospital

Koto-ku,Ariake,3-10-6, Tokyo, Japan

International Medical Center of Japan

Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku,Koutoubashi,4-23-15, Tokyo, Japan

Toyama Prefectural Central Hospital

Toyama,nishinagae,2-2-78, Toyama, Japan

Wakayama Medical University, School of Medicine

Wakayama,Kimiidera,811-1, Wakayama, Japan

Yamagata Prefectural Central Hospital

Yamagata,Aoyagi,1800, Yamagata, Japan

Countries

Japan

Related Links

http://www.jcog.jp/

Related Info

Other Identifiers

C000000279

Identifier Type: REGISTRY

Identifier Source: secondary_id

JCOG0501

Identifier Type: -

Identifier Source: org_study_id