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

This study has been completed.
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group Identifier:
First received: November 10, 2005
Last updated: September 20, 2016
Last verified: September 2016
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.

Condition Intervention Phase
Gastric Neoplasm
Procedure: Gastrectomy with more than D2 dissection
Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • overall survival [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival (PFS) [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • response rate [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • proportion of protocol achievement [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • proportion of curative resection [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]

Enrollment: 316
Study Start Date: November 2005
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Procedure/Surgery: Gastrectomy with more than D2 dissection
Procedure: Gastrectomy with more than D2 dissection
Gastrectomy with more than D2 dissection
Experimental: 2
Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy

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.

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00252161

Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
Fujita Health University
Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan, 470-1192
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
Gifu Municipal Hospital
Gifu,Kashima-cho,7-1, Gifu, Japan, 500-8323
Hiroshima City Hospital
Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan, 730-8518
Itami City Hospital
Itami,Koyaike,1-100, Hyogo, Japan, 664-8540
Iwate Medical University
Morioka,Uchimaru,19-1, Iwate, Japan, 020-8505
Kagoshima University,Faculty of Medicine
Kagoshima,Sakuragaoka,8-35-1, Kagoshima, Japan, 890-8520
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan, 241-0815
Kyoto Second Red Cross Hospital
Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, Japan, 602-8026
Miyagi Cancer Center
Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan, 981-1293
National Hospital Organization, Sendai Medical Center
Sendai,Miyagino-ku,Miyagino,2-8-8, Miyagi, Japan, 983-8520
Nagaoka Chuo General Hospital
Nagaoka,Kawasaki,2041, Niigata, Japan, 940-8653
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
Tsubame Rosai Hospital
Tsubame,Sawatari,633, Niigata, Japan, 959-1228
Oita University Fuculty of Medicine
Oita,Hasama-machi,Oogaoka,1-1, Oita, Japan, 879-5593
Osaka National Hospital
Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan, 540-0006
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
Kinki University School of Medicine
Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan, 589-8511
Sakai Municipal Hospital
Sakai,Minamiyasuicho,1-1-1, Osaka, Japan, 590-0064
Osaka Medical College
Takatsuki,Daigakucho,2-7, Osaka, Japan, 569-0801
Toyonaka Municipal Hospital
Toyonaka,Shibaharacho,4-14-1, Osaka, Japan, 560-0055
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
National Defense Medical College
Tokorozawa,Namiki,3-2, Saitama, Japan, 359-8513
Shizuoka General Hospital
Shizuoka,Aoi-ku,Kitaando,4-27-1, Sizuoka, Japan, 420-8527
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan, 113-8677
Tokyo Medical and Dental University Hospital
Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan, 113-8519
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, Japan, 135-8550
International Medical Center of Japan
Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan, 162-8655
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku,Koutoubashi,4-23-15, Tokyo, Japan, 130-8575
Toyama Prefectural Central Hospital
Toyama,nishinagae,2-2-78, Toyama, Japan, 930-8550
Wakayama Medical University, School of Medicine
Wakayama,Kimiidera,811-1, Wakayama, Japan, 641-8510
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, Japan, 990-2292
Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Study Chair: Mitsuru Sasako, MD, PhD Hyogo College of Medicine
  More Information

Additional Information:
Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group Identifier: NCT00252161     History of Changes
Other Study ID Numbers: JCOG0501  C000000279 
Study First Received: November 10, 2005
Last Updated: September 20, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
Neoadjuvant Therapy
Stomach Neoplasms

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents processed this record on October 21, 2016