NCT00252161

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_3

Geographic Reach
1 country

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

9.4 years

First QC Date

November 10, 2005

Last Update Submit

September 20, 2016

Conditions

Gastric Neoplasm

Keywords

Neoadjuvant TherapyStomach NeoplasmsCisplatinS-1(combination)

Outcome Measures

Primary Outcomes (1)

  • overall survival

    during the study conduct

Secondary Outcomes (5)

  • progression free survival (PFS)

    during the study conduct

  • response rate

    during the study conduct

  • proportion of protocol achievement

    during the study conduct

  • proportion of curative resection

    during the study conduct

  • adverse events

    during the study conduct

Study Arms (2)

1

ACTIVE COMPARATOR

Procedure/Surgery: Gastrectomy with more than D2 dissection

Procedure: Gastrectomy with more than D2 dissection

2

EXPERIMENTAL

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

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

Interventions

Gastrectomy with more than D2 dissectionPROCEDURE

Gastrectomy with more than D2 dissection

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

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

2

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Aichi Cancer Center Hospital

Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681, Japan

Location

Fujita Health University

Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, 470-1192, Japan

Location

National Cancer Center Hospital East

Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, 790-0007, Japan

Location

Gifu Municipal Hospital

Gifu,Kashima-cho,7-1, Gifu, 500-8323, Japan

Location

Hiroshima City Hospital

Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, 730-8518, Japan

Location

Itami City Hospital

Itami,Koyaike,1-100, Hyōgo, 664-8540, Japan

Location

Iwate Medical University

Morioka,Uchimaru,19-1, Iwate, 020-8505, Japan

Location

Kagoshima University,Faculty of Medicine

Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, 890-8520, Japan

Location

Kanagawa Cancer Center

Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, 241-0815, Japan

Location

Kyoto Second Red Cross Hospital

Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, 602-8026, Japan

Location

Miyagi Cancer Center

Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, 981-1293, Japan

Location

National Hospital Organization, Sendai Medical Center

Sendai,Miyagino-ku,Miyagino,2-8-8, Miyagi, 983-8520, Japan

Location

Nagaoka Chuo General Hospital

Nagaoka,Kawasaki,2041, Niigata, 940-8653, Japan

Location

Niigata Cancer Center Hospital

Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566, Japan

Location

Tsubame Rosai Hospital

Tsubame,Sawatari,633, Niigata, 959-1228, Japan

Location

Oita University Fuculty of Medicine

Oita,Hasama-machi,Oogaoka,1-1, Oita Prefecture, 879-5593, Japan

Location

Osaka National Hospital

Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, 540-0006, Japan

Location

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511, Japan

Location

Kinki University School of Medicine

Osaka-Sayama,Ohno-higashi,377-2, Osaka, 589-8511, Japan

Location

Sakai Municipal Hospital

Sakai,Minamiyasuicho,1-1-1, Osaka, 590-0064, Japan

Location

Osaka Medical College

Takatsuki,Daigakucho,2-7, Osaka, 569-0801, Japan

Location

Toyonaka Municipal Hospital

Toyonaka,Shibaharacho,4-14-1, Osaka, 560-0055, Japan

Location

Saitama Cancer Center

Kita-adachi,Ina,Komuro,818, Saitama, 362-0806, Japan

Location

National Defense Medical College

Tokorozawa,Namiki,3-2, Saitama, 359-8513, Japan

Location

Shizuoka General Hospital

Shizuoka,Aoi-ku,Kitaando,4-27-1, Shizuoka, 420-8527, Japan

Location

Tokyo Metropolitan Komagome Hospital

Bunkyo-ku,Honkomagome,3-18-22, Tokyo, 113-8677, Japan

Location

Tokyo Medical and Dental University Hospital

Bunkyo-ku,Yushima,1-5-45, Tokyo, 113-8519, Japan

Location

National Cancer Center Hospital

Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045, Japan

Location

Cancer Institute Hospital

Koto-ku,Ariake,3-10-6, Tokyo, 135-8550, Japan

Location

International Medical Center of Japan

Shinjuku-ku,Toyama,1-21-1, Tokyo, 162-8655, Japan

Location

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku,Koutoubashi,4-23-15, Tokyo, 130-8575, Japan

Location

Toyama Prefectural Central Hospital

Toyama,nishinagae,2-2-78, Toyama, 930-8550, Japan

Location

Wakayama Medical University, School of Medicine

Wakayama,Kimiidera,811-1, Wakayama, 641-8510, Japan

Location

Yamagata Prefectural Central Hospital

Yamagata,Aoyagi,1800, Yamagata, 990-2292, Japan

Location

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastrectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mitsuru Sasako, MD, PhD

    Hyogo Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
JCOG Data Center

Study Record Dates

First Submitted

November 10, 2005

First Posted

November 11, 2005

Study Start

November 1, 2005

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

JP(35)