Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer
A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer
1 other identifier
interventional
628
1 country
116
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 gastric-cancer
Started Mar 2006
116 active sites
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
First Submitted
Initial submission to the registry
February 3, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJune 28, 2011
June 1, 2011
2.5 years
February 3, 2006
June 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
median
Secondary Outcomes (3)
time-to-progression
From onset of regression to progression
response rate
response during observation
safety
side effects during observation
Study Arms (2)
1
EXPERIMENTALDocetaxel + S-1
2
ACTIVE COMPARATORS-1
Interventions
Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (116)
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681, Japan
Aichi Medical University Hospital
Okazaki, Aichi-ken, 480-1195, Japan
Akita University Hospital
Akita, Akita, 010-8543, Japan
Nakadoori General Hospital
Akita, Akita, 010-8577, Japan
Aomori Prefectural Central Hospital
Aomori, Aomori, 030-8553, Japan
Hirosahi University Graduate School of Medicine
Hirosaki, Aomori, 036-8562, Japan
Hirosaki Unuversity,School of Medicine
Hirosaki, Aomori, 036-8562, Japan
Misawa City Hospital
Misawa, Aomori, 033-0001, Japan
Department of frontier surgery Graduate school of medicine,Chiba University
Chiba, Chiba, 260-8670, Japan
Department of Organ kegulatory Surgery (First Department Surgery),Ehime University Graduate School of Medicine
Ehime, Ehime, 791-0295, Japan
Matsuyama Simin Hospital
Matsuyama, Ehime, 790-0067, Japan
Fukui Prefectural Hospital
Fukui-shi, Fukui, 910-0846, Japan
Fukui Red Cross Hospital
Fukui-shi, Fukui, 918-8501, Japan
Saiseikai Hospital
Fukui-shi, Fukui, 918-8503, Japan
Saiseikai Fukuoka General Hospital
Fukuoka, Fukuoka, 810-0001, Japan
National Kyusyu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Kyusyu University Faculty of Medical Sciences
Fukuoka, Fukuoka, 812-8582, Japan
Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuoka, Fukuoka, 815-8588, Japan
Iizuka Hospital
Iizuka, Fukuoka, 820-8505, Japan
Nippon Steel Yawata Memorial Hospital
Kitakyushu, Fukuoka, 805-8508, Japan
Universsity of Occupational and Environmental Health,Japan
Kitakyushu, Fukuoka, 807-8550, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295, Japan
Gifu Municipal Hospital
Gifu, Gifu, 500-8513, Japan
Gifu University School of Medicine
Gifu, Gifu, 501-1193, Japan
Gifu Prefectural Gifu Hospital
Gifu, Gifu, ５００-８７１７, Japan
Ibi Kose Hospital
Ibi, Gifu, 501-0619, Japan
Gunma University Hospital
Maehashi, Gunma, 371-0034, Japan
Gunma Prefectural Cancer Center
Oota, Gunma, 373-8550, Japan
Fukuyama City Hospital
Fukuyama, Hiroshima, 721-8511, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Hiroshima, 730-8619, Japan
Horoshima City Asa Hospital
Hiroshima, Hiroshima, 731-0293, Japan
Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery
Hiroshima, Hiroshima, 734-8553, Japan
National Hospital Organization Kure Medical Center
Kure, Hiroshima, 737-0023, Japan
Asahikawa-Kosei General Hospital
Asahikawa, Hokkaido, 078-8211, Japan
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, 078-8510, Japan
Hakodate Goryoukaku Hopsital
Hakodate, Hokkaido, 040-0001, Japan
Kushiro City General Hospital
Kushiro, Hokkaido, 085-0822, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543, Japan
Kinki Central Hospital
Itami, Hyōgo, 662-8533, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Hyogo College Of Medicine
Nishimiya, Hyōgo, 663-8501, Japan
Hitachi General Hospital
Hitachi, Ibaragi, MD, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530, Japan
Kanazawa Medical School Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kanazawa Medical University Hospital
Nakajima, Ishikawa-ken, 920-0293, Japan
Keiju Medical Center
Nanao, Ishikawa-ken, 926-8605, Japan
Iwate Medical University Hospital
Morioka, Iwate, 020-8505, Japan
Morioka Red Cross Hospital
Morioka, Iwate, 020-8560, Japan
Department of surgical oncology and digestive surgery kagoshima university graduate school
Kagoshima, Kagoshima-ken, 890-8520, Japan
Tokai Medical University Hospital
Isehara, Kanagawa, 259-1193, Japan
St.Marianna University School of Medicine
Kawasaki, Kanagawa, 216-8511, Japan
Kitasato University East Hospital
Sagamihara, Kanagawa, 228-8520, Japan
Showa University Fujigaoka Hospital
Yokohama, Kanagawa, 227-8501, Japan
Yokohama Citizen's Municipal Hospital
Yokohama, Kanagawa, 240-8550, Japan
St. Marianna University School of Medicine,Yokohama City Seibu Hospital
Yokohama, Kanagawa, 241-0811, Japan
Kanagawa Prefectural Cancer Center
Yokohama, Kanagawa, 241-0815, Japan
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, MD, Japan
Kochi Health Sciences Center
Kochi, Kochi, 781-8555, Japan
Kumamoto Medical University Hospital
Kumamoto, Kumamoto, MD, Japan
Kyoto University Hospital
Kyoto, Kyoto, 506-8507, Japan
University Hospital,Kyoto Prefectural University of Medicien
Kyoto, Kyoto, 602-8566, Japan
Tohoku Rosai Hospital
Sendai, Miyagi, 980-8574, Japan
Institute of Development,Aging and Cancer,Tohoku University
Sendai, Miyagi, 980-8575, Japan
Nagano Municipal Hospital
Nagano, Nagano, 381-0006, Japan
Hokushin Synthesis Hospital
Nakano, Nagano, 383-8505, Japan
Nagasaki University Graduate School of Biomedical Sciences
Nagasaki, Nagasaki, 852-850, Japan
National Hospital Organization Nagasaki Medical Center
Oomura, Nagasaki, 856-8562, Japan
National Hospital Organization Nagoya Medical Center
Nagoya, Nagoya, 460-0001, Japan
Nara Medical University Hospital
Kashihara, Nara, 634-8851, Japan
Niigata Prefectural Cancer Center
Niigata, Niigata, 951-8566, Japan
Oita Prefectural Hospital
Ōita, Oita Prefecture, 870-8511, Japan
Kaneda Hospital
Maniwa, Okayama-ken, 719-3105, Japan
Hospital, University of the Ryukyus
Chutougun, Okinawa, 903-0215, Japan
Rinku General Medical Center
Izumisano, Osaka, 598-0048, Japan
Kimen Municipal Hospital
Kimen, Osaka, 562-8562, Japan
National Hospital Organization Osaka National Hospital
Osaka, Osaka, 540-0006, Japan
Osaka City University Graduate School of Medicine
Osaka, Osaka, 545-8585, Japan
Osaka General Medical Center
Osaka, Osaka, 558-8558, Japan
Sakai Municipal Hospital
Sakai, Osaka, 590-0064, Japan
Kinki Medical University Hospital
Sayama, Osaka, 589-8511, Japan
Toyonaka Municipal Hospital
Toyonaka, Osaka, 560-8565, Japan
Yao Municipal Hospital
Yao, Osaka, 581-0069, Japan
Saga Medical School Hospital
Saga, Saga-ken, 849-8501, Japan
Otsu Municipal Hospital
Ōtsu, Shiga, 520-0804, Japan
Saiseikai Shiga Hospital
Rittō, Shiga, 520-3046, Japan
Shimane University Faculty of Medicine
Izumo, Shimane, 693-8501, Japan
Takarazuka City Hospital
Hyōgo, Takarazuka, 665-0827, Japan
Jichi Medical School Hospital
Shimono, Tochigi, 329-0498, Japan
Dokkyo University School of Medecine
Shimotsuga, Tochigi, 321-0293, Japan
Tokushima Red Cross Hospital
Komatsushimachō, Tokushima, 773-8502, Japan
Tokyo Medical and Dental University Hospital Faculty of Medicine
Bunkyo-ku, Tokyo, 113-8519, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677, Japan
Surugadai Nihon University Hospital
Chiyoda-ku, Tokyo, 101-8309, Japan
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, 193-0998, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, 173-8606, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, 173-8610, Japan
Cancer Institute Hospital
Koto-ku, Tokyo, 135-8550, Japan
Japan Clinical Cancer Research Organization
Koto-ku, Tokyo, 135-8550, Japan
Showa University Toyosu Hospital
Koto-ku, Tokyo, 135-8577, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, 152-0021, Japan
Toho University Ohashi Medical Center
Meguro-ku, Tokyo, 153-8515, Japan
Toranomon Hospital
Minato-ku, Tokyo, 105-8470, Japan
The Jikei University
Minato-ku, Tokyo, 105-8471, Japan
International University of Health and Welfare Mita Hospital
Minato-ku, Tokyo, 108-8329, Japan
Kyorin University Hospital
Mitaka, Tokyo, 181-8611, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, 142-8666, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
International Medical Center of Japan
Shinjuku-ku, Tokyo, 162-8655, Japan
Social Insurange Central General Hospital
Shinjuku-ku, Tokyo, 169-0073, Japan
Tottori University Faculty of Medicine
Yonago, Tottori, 683-8504, Japan
Kouseiren Takaoka Hospital
Takaoka, Toyama, 933-8555, Japan
Yamagata Prefectural Central Hospital
Yamagata, Yamagata, 990-2292, Japan
Yamanashi Prefectural Central Hospital
Kohfu, Yamanashi, 400-8506, Japan
Related Publications (3)
Arai H, Takeuchi M, Ichikawa W, Shitara K, Sunakawa Y, Oba K, Koizumi W, Sakata Y, Furukawa H, Yamada Y, Takeuchi M, Fujii M. Correlation of multiple endpoints in the first-line chemotherapy of advanced gastric cancer: Pooled analysis of individual patient data from Japanese Phase III trials. Cancer Med. 2024 Jan;13(1):e6818. doi: 10.1002/cam4.6818. Epub 2023 Dec 23.
PMID: 38140879DERIVEDKoizumi 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.
PMID: 24366758DERIVEDFujii 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.
PMID: 18553228DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Masashi Fujii, MD PhD
Surugadai Nihon University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 3, 2006
First Posted
February 7, 2006
Study Start
March 1, 2006
Primary Completion
September 1, 2008
Study Completion
October 1, 2010
Last Updated
June 28, 2011
Record last verified: 2011-06