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Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
docetaxel + S-1
S-1
Sponsored by
Japan Clinical Cancer Research Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, advanced gastric cancer, S-1, docetaxel, phase III study

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma Subjects must be able to take orally Measurable lesion and/or non-measurable lesion defined by RECIST ECOG performance status ≦ 1 Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3 Creatine ≦ upper normal limit (UNL) Total bilirubin ≦ 1.5 X UNL AST, ALT and ALP ≦ 2.5 x UNL No prior chemotherapy Life expectancy estimated than 3 months Written informed consent Exclusion Criteria: Active double cancer Gastrointestinal bleeding Excessive amounts of ascites require drainage Known brain metastases Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0 Pulmonary fibrosis, Intestinal pneumonitis History of hypersensitivity to fluoropyrimidines, docetaxel or medications formulated with polysorbate 80 Any previous chemotherapy or radiotherapy for AGC Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant Treatment with any investigational product during the last 4 weeks prior to study entry Definite contraindications for the use of corticosteroids Any subject judged by the investigator to be unfit for any reason to participate in the study

Sites / Locations

  • Aichi Cancer Center
  • Hirosahi University Graduate School of Medicine
  • Hirosaki Unuversity,School of Medicine
  • Misawa City Hospital
  • Matsuyama Simin Hospital
  • Iizuka Hospital
  • Nippon Steel Yawata Memorial Hospital
  • Universsity of Occupational and Environmental Health,Japan
  • Kurume University Hospital
  • Ibi Kose Hospital
  • Gunma University Hospital
  • Gunma Prefectural Cancer Center
  • Fukuyama City Hospital
  • National Hospital Organization Kure Medical Center
  • Asahikawa-Kosei General Hospital
  • Asahikawa Medical College Hospital
  • Hakodate Goryoukaku Hopsital
  • Kushiro City General Hospital
  • National Hospital Organization Hokkaido Cancer Center
  • Sapporo Medical University Hospital
  • Kinki Central Hospital
  • Kobe University Hospital
  • Hyogo College Of Medicine
  • Hitachi General Hospital
  • Ishikawa Prefectural Central Hospital
  • Kanazawa Medical School Hospital
  • Kanazawa Medical University Hospital
  • Keiju Medical Center
  • Iwate Medical University Hospital
  • Morioka Red Cross Hospital
  • Tokai Medical University Hospital
  • St.Marianna University School of Medicine
  • Kitasato University East Hospital
  • Showa University Fujigaoka Hospital
  • Yokohama Citizen's Municipal Hospital
  • St. Marianna University School of Medicine,Yokohama City Seibu Hospital
  • Kanagawa Prefectural Cancer Center
  • Showa University Northern Yokohama Hospital
  • Tohoku Rosai Hospital
  • Institute of Development,Aging and Cancer,Tohoku University
  • Hokushin Synthesis Hospital
  • National Hospital Organization Nagasaki Medical Center
  • Nara Medical University Hospital
  • Kaneda Hospital
  • Hospital, University of the Ryukyus
  • Rinku General Medical Center
  • Kimen Municipal Hospital
  • Sakai Municipal Hospital
  • Kinki Medical University Hospital
  • Toyonaka Municipal Hospital
  • Yao Municipal Hospital
  • Otsu Municipal Hospital
  • Saiseikai Shiga Hospital
  • Shimane University Faculty of Medicine
  • Takarazuka City Hospital
  • Jichi Medical School Hospital
  • Dokkyo University School of Medecine
  • Tokushima Red Cross Hospital
  • Tokyo Medical and Dental University Hospital Faculty of Medicine
  • Tokyo Metropolitan Komagome Hospital
  • Surugadai Nihon University Hospital
  • Tokyo Medical University Hachioji Medical Center
  • Teikyo University Hospital
  • Nihon University Itabashi Hospital
  • Cancer Institute Hospital
  • Japan Clinical Cancer Research Organization
  • Showa University Toyosu Hospital
  • National Hospital Organization Tokyo Medical Center
  • Toho University Ohashi Medical Center
  • Toranomon Hospital
  • The Jikei University
  • International University of Health and Welfare Mita Hospital
  • Kyorin University Hospital
  • Showa University Hospital
  • Tokyo Medical University Hospital
  • Keio University Hospital
  • International Medical Center of Japan
  • Social Insurange Central General Hospital
  • Tottori University Faculty of Medicine
  • Kouseiren Takaoka Hospital
  • Yamanashi Prefectural Central Hospital
  • Aichi Medical University Hospital
  • Akita University Hospital
  • Nakadoori General Hospital
  • Aomori Prefectural Central Hospital
  • Department of frontier surgery Graduate school of medicine,Chiba University
  • Department of Organ kegulatory Surgery (First Department Surgery),Ehime University Graduate School of Medicine
  • Fukui Prefectural Hospital
  • Fukui Red Cross Hospital
  • Saiseikai Hospital
  • Saiseikai Fukuoka General Hospital
  • National Kyusyu Cancer Center
  • Kyusyu University Faculty of Medical Sciences
  • Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers
  • Fukushima Medical University Hospital
  • Gifu Municipal Hospital
  • Gifu University School of Medicine
  • Gifu Prefectural Gifu Hospital
  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
  • Horoshima City Asa Hospital
  • Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery
  • Department of surgical oncology and digestive surgery kagoshima university graduate school
  • Kochi Health Sciences Center
  • Kumamoto Medical University Hospital
  • Kyoto University Hospital
  • University Hospital,Kyoto Prefectural University of Medicien
  • Nagano Municipal Hospital
  • Nagasaki University Graduate School of Biomedical Sciences
  • National Hospital Organization Nagoya Medical Center
  • Niigata Prefectural Cancer Center
  • Oita Prefectural Hospital
  • National Hospital Organization Osaka National Hospital
  • Osaka City University Graduate School of Medicine
  • Osaka General Medical Center
  • Saga Medical School Hospital
  • Yamagata Prefectural Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Docetaxel + S-1

S-1

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

time-to-progression
response rate
safety

Full Information

First Posted
February 3, 2006
Last Updated
June 27, 2011
Sponsor
Japan Clinical Cancer Research Organization
Collaborators
Korean Cancer Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00287768
Brief Title
Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer
Official Title
A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Clinical Cancer Research Organization
Collaborators
Korean Cancer Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to compare median overall survival of the test arm (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent gastric cancer.
Detailed Description
Seven-hundred and fifty thousand of new gastric cancer cases are diagnosed worldwide per year. Advanced gastric cancer (AGC) is considered nearly incurable with less than 10% of subjects alive 5 years after diagnosis. Therefore, new treatment regimens are needed for subjects with AGC. S-1, a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur (ftorafur, FT) and two enzyme inhibitors, CDHP (5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate), in a molar ratio of 1(FT):0.4 (CDHP):1(OXO) is commercially available since late 90'in Japan. Phase II trials have demonstrated that S-1 is active, as a single agent, for the treatment of gastric (RR 44.6%), colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and pancreatic cancers. In gastric cancer, phase III trials (JCOG 9912) comparing 5-FU alone and CPT-11/CDDP combination are currently underway and these results are awaited. Despite of JCOG 9912 study is ongoing, 80% of patients of AGC are already treated by S-1, because of high RR and convenience use for out-patient basis. P-II studies S-1/CDDP, S-1/CPT-11 and S-1/Docetaxel showed high RR(55-76%) and long MST(12-14M). Furthermore, P-III studies are already conducted S-1 vs. S-1/CDDP and S-1 vs. S-1/CPT-11 in Japan. The aim of this study is to compare S-1/Docetaxel vs. S-1 alone in the patients of AGC. This study is a prospective, multicenter, multinational, non-blinded, randomized phase III study. Patients: Inoperable or relapse gastric cancer. Informed consent must be obtained in writing before treatment. Subjects meeting all of the inclusion criteria and exclusion criteria will be considered for enrollment into study. Then patients will be randomly assigned into two groups S-1/Docetaxel(Treatment Arm A) or S-1 alone(Treatment Arm B).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, advanced gastric cancer, S-1, docetaxel, phase III study

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Docetaxel + S-1
Arm Title
2
Arm Type
Active Comparator
Arm Description
S-1
Intervention Type
Drug
Intervention Name(s)
docetaxel + S-1
Other Intervention Name(s)
taxotere, TS-1
Intervention Description
Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
TS-1
Intervention Description
S-1 po days 1-28 every 6 weeks
Primary Outcome Measure Information:
Title
overall survival
Time Frame
median
Secondary Outcome Measure Information:
Title
time-to-progression
Time Frame
From onset of regression to progression
Title
response rate
Time Frame
response during observation
Title
safety
Time Frame
side effects during observation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma Subjects must be able to take orally Measurable lesion and/or non-measurable lesion defined by RECIST ECOG performance status ≦ 1 Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3 Creatine ≦ upper normal limit (UNL) Total bilirubin ≦ 1.5 X UNL AST, ALT and ALP ≦ 2.5 x UNL No prior chemotherapy Life expectancy estimated than 3 months Written informed consent Exclusion Criteria: Active double cancer Gastrointestinal bleeding Excessive amounts of ascites require drainage Known brain metastases Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0 Pulmonary fibrosis, Intestinal pneumonitis History of hypersensitivity to fluoropyrimidines, docetaxel or medications formulated with polysorbate 80 Any previous chemotherapy or radiotherapy for AGC Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant Treatment with any investigational product during the last 4 weeks prior to study entry Definite contraindications for the use of corticosteroids Any subject judged by the investigator to be unfit for any reason to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masashi Fujii, MD PhD
Organizational Affiliation
Surugadai Nihon University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aichi Cancer Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Hirosahi University Graduate School of Medicine
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8562
Country
Japan
Facility Name
Hirosaki Unuversity,School of Medicine
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8562
Country
Japan
Facility Name
Misawa City Hospital
City
Misawa
State/Province
Aomori
ZIP/Postal Code
033-0001
Country
Japan
Facility Name
Matsuyama Simin Hospital
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
790-0067
Country
Japan
Facility Name
Iizuka Hospital
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Nippon Steel Yawata Memorial Hospital
City
Kitakyusyu
State/Province
Fukuoka
ZIP/Postal Code
805-8508
Country
Japan
Facility Name
Universsity of Occupational and Environmental Health,Japan
City
Kitakyusyu
State/Province
Fukuoka
ZIP/Postal Code
807-8550
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Ibi Kose Hospital
City
Ibi
State/Province
Gifu
ZIP/Postal Code
501-0619
Country
Japan
Facility Name
Gunma University Hospital
City
Maehashi
State/Province
Gunma
ZIP/Postal Code
371-0034
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Oota
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
Fukuyama City Hospital
City
Fukuyama
State/Province
Hiroshima
ZIP/Postal Code
721-8511
Country
Japan
Facility Name
National Hospital Organization Kure Medical Center
City
Kure
State/Province
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Facility Name
Asahikawa-Kosei General Hospital
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8211
Country
Japan
Facility Name
Asahikawa Medical College Hospital
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Hakodate Goryoukaku Hopsital
City
Hakodate
State/Province
Hokkaido
ZIP/Postal Code
040-0001
Country
Japan
Facility Name
Kushiro City General Hospital
City
Kushiro
State/Province
Hokkaido
ZIP/Postal Code
085-0822
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Kinki Central Hospital
City
Itan
State/Province
Hyogo
ZIP/Postal Code
662-8533
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Hyogo College Of Medicine
City
Nishimiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Hitachi General Hospital
City
Hitachi
State/Province
Ibaragi
ZIP/Postal Code
MD
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Kanazawa Medical School Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kanazawa Medical University Hospital
City
Kawakita
State/Province
Ishikawa
ZIP/Postal Code
920-0293
Country
Japan
Facility Name
Keiju Medical Center
City
Nanao
State/Province
Ishikawa
ZIP/Postal Code
926-8605
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Morioka Red Cross Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8560
Country
Japan
Facility Name
Tokai Medical University Hospital
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
St.Marianna University School of Medicine
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kitasato University East Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-8520
Country
Japan
Facility Name
Showa University Fujigaoka Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
227-8501
Country
Japan
Facility Name
Yokohama Citizen's Municipal Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
240-8550
Country
Japan
Facility Name
St. Marianna University School of Medicine,Yokohama City Seibu Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-0811
Country
Japan
Facility Name
Kanagawa Prefectural Cancer Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Showa University Northern Yokohama Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
MD
Country
Japan
Facility Name
Tohoku Rosai Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Institute of Development,Aging and Cancer,Tohoku University
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8575
Country
Japan
Facility Name
Hokushin Synthesis Hospital
City
Nakano
State/Province
Nagano
ZIP/Postal Code
383-8505
Country
Japan
Facility Name
National Hospital Organization Nagasaki Medical Center
City
Oomura
State/Province
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8851
Country
Japan
Facility Name
Kaneda Hospital
City
Maniwa
State/Province
Okayama
ZIP/Postal Code
719-3105
Country
Japan
Facility Name
Hospital, University of the Ryukyus
City
Chutougun
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Rinku General Medical Center
City
Izumisano
State/Province
Osaka
ZIP/Postal Code
598-0048
Country
Japan
Facility Name
Kimen Municipal Hospital
City
Kimen
State/Province
Osaka
ZIP/Postal Code
562-8562
Country
Japan
Facility Name
Sakai Municipal Hospital
City
Sakai
State/Province
Osaka
ZIP/Postal Code
590-0064
Country
Japan
Facility Name
Kinki Medical University Hospital
City
Sayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Toyonaka Municipal Hospital
City
Toyonaka
State/Province
Osaka
ZIP/Postal Code
560-8565
Country
Japan
Facility Name
Yao Municipal Hospital
City
Yao
State/Province
Osaka
ZIP/Postal Code
581-0069
Country
Japan
Facility Name
Otsu Municipal Hospital
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-0804
Country
Japan
Facility Name
Saiseikai Shiga Hospital
City
Ritto
State/Province
Shiga
ZIP/Postal Code
520-3046
Country
Japan
Facility Name
Shimane University Faculty of Medicine
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Takarazuka City Hospital
City
Hyogo
State/Province
Takarazuka
ZIP/Postal Code
665-0827
Country
Japan
Facility Name
Jichi Medical School Hospital
City
Shimono
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Dokkyo University School of Medecine
City
Shimotsuga
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Tokushima Red Cross Hospital
City
Komatsushima
State/Province
Tokushima
ZIP/Postal Code
773-8502
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital Faculty of Medicine
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Tokyo Metropolitan Komagome Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Surugadai Nihon University Hospital
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
Teikyo University Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Cancer Institute Hospital
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Japan Clinical Cancer Research Organization
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Showa University Toyosu Hospital
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8577
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-0021
Country
Japan
Facility Name
Toho University Ohashi Medical Center
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
153-8515
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
The Jikei University
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
International University of Health and Welfare Mita Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8329
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Showa University Hospital
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
International Medical Center of Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Social Insurange Central General Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Tottori University Faculty of Medicine
City
Yonago
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Kouseiren Takaoka Hospital
City
Takaoka
State/Province
Toyama
ZIP/Postal Code
933-8555
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital
City
Kohfu
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Aichi Medical University Hospital
City
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Akita University Hospital
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Nakadoori General Hospital
City
Akita
ZIP/Postal Code
010-8577
Country
Japan
Facility Name
Aomori Prefectural Central Hospital
City
Aomori
ZIP/Postal Code
030-8553
Country
Japan
Facility Name
Department of frontier surgery Graduate school of medicine,Chiba University
City
Chiba
ZIP/Postal Code
260-8670
Country
Japan
Facility Name
Department of Organ kegulatory Surgery (First Department Surgery),Ehime University Graduate School of Medicine
City
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Fukui Prefectural Hospital
City
Fukui
ZIP/Postal Code
910-0846
Country
Japan
Facility Name
Fukui Red Cross Hospital
City
Fukui
ZIP/Postal Code
918-8501
Country
Japan
Facility Name
Saiseikai Hospital
City
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
Saiseikai Fukuoka General Hospital
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Facility Name
National Kyusyu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kyusyu University Faculty of Medical Sciences
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers
City
Fukuoka
ZIP/Postal Code
815-8588
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Gifu Municipal Hospital
City
Gifu
ZIP/Postal Code
500-8513
Country
Japan
Facility Name
Gifu University School of Medicine
City
Gifu
ZIP/Postal Code
501-1193
Country
Japan
Facility Name
Gifu Prefectural Gifu Hospital
City
Gifu
ZIP/Postal Code
５００-８７１７
Country
Japan
Facility Name
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
City
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Facility Name
Horoshima City Asa Hospital
City
Hiroshima
ZIP/Postal Code
731-0293
Country
Japan
Facility Name
Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery
City
Hiroshima
ZIP/Postal Code
734-8553
Country
Japan
Facility Name
Department of surgical oncology and digestive surgery kagoshima university graduate school
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Kochi Health Sciences Center
City
Kochi
ZIP/Postal Code
781-8555
Country
Japan
Facility Name
Kumamoto Medical University Hospital
City
Kumamoto
ZIP/Postal Code
MD
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
506-8507
Country
Japan
Facility Name
University Hospital,Kyoto Prefectural University of Medicien
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Nagano Municipal Hospital
City
Nagano
ZIP/Postal Code
381-0006
Country
Japan
Facility Name
Nagasaki University Graduate School of Biomedical Sciences
City
Nagasaki
ZIP/Postal Code
852-850
Country
Japan
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Niigata Prefectural Cancer Center
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Oita Prefectural Hospital
City
Oita
ZIP/Postal Code
870-8511
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka City University Graduate School of Medicine
City
Osaka
ZIP/Postal Code
545-8585
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Saga Medical School Hospital
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata
ZIP/Postal Code
990-2292
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24366758
Citation
Koizumi W, Kim YH, Fujii M, Kim HK, Imamura H, Lee KH, Hara T, Chung HC, Satoh T, Cho JY, Hosaka H, Tsuji A, Takagane A, Inokuchi M, Tanabe K, Okuno T, Ogura M, Yoshida K, Takeuchi M, Nakajima T; JACCRO and KCSG Study Group. Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer: a randomized study (START). J Cancer Res Clin Oncol. 2014 Feb;140(2):319-28. doi: 10.1007/s00432-013-1563-5. Epub 2013 Dec 24.
Results Reference
derived
PubMed Identifier
18553228
Citation
Fujii M; 0. Chemotherapy for advanced gastric cancer: ongoing phase III study of S-1 alone versus S-1 and docetaxel combination (JACCRO GC03 study). Int J Clin Oncol. 2008 Jun;13(3):201-5. doi: 10.1007/s10147-008-0775-1. Epub 2008 Jun 14.
Results Reference
derived

Learn more about this trial

Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer

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