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

Gastric Neoplasm Clinical Trial

Official title:

Randomized Phase III Trial of Surgery Plus Neoadjuvant TS-1 and Cisplatin Compared With Surgery Alone for Type 4 and Large Type 3 Gastric Cancer: Japan Clinical Oncology Group Study (JCOG 0501)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252161
• Other study ID #: JCOG0501
• Secondary ID: C000000279
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2005
• Last updated: September 20, 2016
• Start date: November 2005
• Est. completion date: April 2015

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Neoplasm
• Stomach Neoplasms

Intervention

Procedure:
• Gastrectomy with more than D2 dissection
Gastrectomy with more than D2 dissection

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

Locations

Country	Name	City	State
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	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	Hyogo
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	National Cancer Center Hospital East	Kashiwa,Kashiwanoha,6-5-1	Chiba
Japan	Saitama Cancer Center	Kita-adachi,Ina,Komuro,818	Saitama
Japan	Cancer Institute Hospital	Koto-ku,Ariake,3-10-6	Tokyo
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama,Horinouchi,13	Ehime
Japan	Iwate Medical University	Morioka,Uchimaru,19-1	Iwate
Japan	Nagaoka Chuo General Hospital	Nagaoka,Kawasaki,2041	Niigata
Japan	Aichi Cancer Center Hospital	Nagoya,Chikusa-ku,Kanokoden,1-1	Aichi
Japan	Miyagi Cancer Center	Natori,Medeshima-Shiode,Nodayama,47-1	Miyagi
Japan	Niigata Cancer Center Hospital	Niigata,Kawagishi-cho,2-15-3	Niigata
Japan	Oita University Fuculty of Medicine	Oita,Hasama-machi,Oogaoka,1-1	Oita
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	National Hospital Organization, Sendai Medical Center	Sendai,Miyagino-ku,Miyagino,2-8-8	Miyagi
Japan	International Medical Center of Japan	Shinjuku-ku,Toyama,1-21-1	Tokyo
Japan	Shizuoka General Hospital	Shizuoka,Aoi-ku,Kitaando,4-27-1	Sizuoka
Japan	Tokyo Metropolitan Bokutoh Hospital	Sumida-ku,Koutoubashi,4-23-15	Tokyo
Japan	Osaka Medical College	Takatsuki,Daigakucho,2-7	Osaka
Japan	National Defense Medical College	Tokorozawa,Namiki,3-2	Saitama
Japan	Toyama Prefectural Central Hospital	Toyama,nishinagae,2-2-78	Toyama
Japan	Fujita Health University	Toyoake,Kutsukake-cho,Dengakugakubo,1-98	Aichi
Japan	Toyonaka Municipal Hospital	Toyonaka,Shibaharacho,4-14-1	Osaka
Japan	Tsubame Rosai Hospital	Tsubame,Sawatari,633	Niigata
Japan	Wakayama Medical University, School of Medicine	Wakayama,Kimiidera,811-1	Wakayama
Japan	Yamagata Prefectural Central Hospital	Yamagata,Aoyagi,1800	Yamagata
Japan	Kanagawa Cancer Center	Yokohama,Asahi-ku,Nakao,1-1-2	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Haruhiko Fukuda	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		during the study conduct	No
Secondary	progression free survival (PFS)		during the study conduct	No
Secondary	response rate		during the study conduct	No
Secondary	proportion of protocol achievement		during the study conduct	No
Secondary	proportion of curative resection		during the study conduct	No
Secondary	adverse events		during the study conduct	Yes

External Links

•   Link