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

Primary Purpose

Gastric Neoplasm

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Gastrectomy with more than D2 dissection
Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Sponsored by
Haruhiko Fukuda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Neoplasm focused on measuring Neoadjuvant Therapy, Stomach Neoplasms, Cisplatin, S-1(combination)

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Aichi Cancer Center Hospital
  • Fujita Health University
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • Gifu Municipal Hospital
  • Hiroshima City Hospital
  • Itami City Hospital
  • Iwate Medical University
  • Kagoshima University,Faculty of Medicine
  • Kanagawa Cancer Center
  • Kyoto Second Red Cross Hospital
  • Miyagi Cancer Center
  • National Hospital Organization, Sendai Medical Center
  • Nagaoka Chuo General Hospital
  • Niigata Cancer Center Hospital
  • Tsubame Rosai Hospital
  • Oita University Fuculty of Medicine
  • Osaka National Hospital
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Kinki University School of Medicine
  • Sakai Municipal Hospital
  • Osaka Medical College
  • Toyonaka Municipal Hospital
  • Saitama Cancer Center
  • National Defense Medical College
  • Shizuoka General Hospital
  • Tokyo Metropolitan Komagome Hospital
  • Tokyo Medical and Dental University Hospital
  • National Cancer Center Hospital
  • Cancer Institute Hospital
  • International Medical Center of Japan
  • Tokyo Metropolitan Bokutoh Hospital
  • Toyama Prefectural Central Hospital
  • Wakayama Medical University, School of Medicine
  • Yamagata Prefectural Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Procedure/Surgery: Gastrectomy with more than D2 dissection

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

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

progression free survival (PFS)
response rate
proportion of protocol achievement
proportion of curative resection
adverse events

Full Information

First Posted
November 10, 2005
Last Updated
September 20, 2016
Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00252161
Brief Title
A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Neoplasm
Keywords
Neoadjuvant Therapy, Stomach Neoplasms, Cisplatin, S-1(combination)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
316 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: Gastrectomy with more than D2 dissection
Arm Title
2
Arm Type
Experimental
Arm Description
Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Gastrectomy with more than D2 dissection
Intervention Description
Gastrectomy with more than D2 dissection
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Intervention Description
Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Primary Outcome Measure Information:
Title
overall survival
Time Frame
during the study conduct
Secondary Outcome Measure Information:
Title
progression free survival (PFS)
Time Frame
during the study conduct
Title
response rate
Time Frame
during the study conduct
Title
proportion of protocol achievement
Time Frame
during the study conduct
Title
proportion of curative resection
Time Frame
during the study conduct
Title
adverse events
Time Frame
during the study conduct

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitsuru Sasako, MD, PhD
Organizational Affiliation
Hyogo Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center Hospital
City
Nagoya,Chikusa-ku,Kanokoden,1-1
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Fujita Health University
City
Toyoake,Kutsukake-cho,Dengakugakubo,1-98
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa,Kashiwanoha,6-5-1
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama,Horinouchi,13
State/Province
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
Gifu Municipal Hospital
City
Gifu,Kashima-cho,7-1
State/Province
Gifu
ZIP/Postal Code
500-8323
Country
Japan
Facility Name
Hiroshima City Hospital
City
Hiroshima,Naka-ku,Motomachi,7-33
State/Province
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Itami City Hospital
City
Itami,Koyaike,1-100
State/Province
Hyogo
ZIP/Postal Code
664-8540
Country
Japan
Facility Name
Iwate Medical University
City
Morioka,Uchimaru,19-1
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Kagoshima University,Faculty of Medicine
City
Kagoshima,Sakuragaoka,8-35-1
State/Province
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama,Asahi-ku,Nakao,1-1-2
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Kyoto Second Red Cross Hospital
City
Kamigyo-ku,Kamanza-Marutamachi,355-5
State/Province
Kyoto
ZIP/Postal Code
602-8026
Country
Japan
Facility Name
Miyagi Cancer Center
City
Natori,Medeshima-Shiode,Nodayama,47-1
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
National Hospital Organization, Sendai Medical Center
City
Sendai,Miyagino-ku,Miyagino,2-8-8
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Nagaoka Chuo General Hospital
City
Nagaoka,Kawasaki,2041
State/Province
Niigata
ZIP/Postal Code
940-8653
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata,Kawagishi-cho,2-15-3
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Tsubame Rosai Hospital
City
Tsubame,Sawatari,633
State/Province
Niigata
ZIP/Postal Code
959-1228
Country
Japan
Facility Name
Oita University Fuculty of Medicine
City
Oita,Hasama-machi,Oogaoka,1-1
State/Province
Oita
ZIP/Postal Code
879-5593
Country
Japan
Facility Name
Osaka National Hospital
City
Osaka,Chuo-ku,Hoenzaka,2-1-14
State/Province
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka,Higashinari-ku,Nakamichi,1-3-3
State/Province
Osaka
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
Kinki University School of Medicine
City
Osaka-Sayama,Ohno-higashi,377-2
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Sakai Municipal Hospital
City
Sakai,Minamiyasuicho,1-1-1
State/Province
Osaka
ZIP/Postal Code
590-0064
Country
Japan
Facility Name
Osaka Medical College
City
Takatsuki,Daigakucho,2-7
State/Province
Osaka
ZIP/Postal Code
569-0801
Country
Japan
Facility Name
Toyonaka Municipal Hospital
City
Toyonaka,Shibaharacho,4-14-1
State/Province
Osaka
ZIP/Postal Code
560-0055
Country
Japan
Facility Name
Saitama Cancer Center
City
Kita-adachi,Ina,Komuro,818
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
National Defense Medical College
City
Tokorozawa,Namiki,3-2
State/Province
Saitama
ZIP/Postal Code
359-8513
Country
Japan
Facility Name
Shizuoka General Hospital
City
Shizuoka,Aoi-ku,Kitaando,4-27-1
State/Province
Sizuoka
ZIP/Postal Code
420-8527
Country
Japan
Facility Name
Tokyo Metropolitan Komagome Hospital
City
Bunkyo-ku,Honkomagome,3-18-22
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-ku,Yushima,1-5-45
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku,Tsukiji,5-1-1
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Cancer Institute Hospital
City
Koto-ku,Ariake,3-10-6
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
International Medical Center of Japan
City
Shinjuku-ku,Toyama,1-21-1
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Tokyo Metropolitan Bokutoh Hospital
City
Sumida-ku,Koutoubashi,4-23-15
State/Province
Tokyo
ZIP/Postal Code
130-8575
Country
Japan
Facility Name
Toyama Prefectural Central Hospital
City
Toyama,nishinagae,2-2-78
State/Province
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Wakayama Medical University, School of Medicine
City
Wakayama,Kimiidera,811-1
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata,Aoyagi,1800
State/Province
Yamagata
ZIP/Postal Code
990-2292
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.jcog.jp/
Description
Related Info

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

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