Clinical trial NCT00287768: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: gastric cancer
advanced gastric cancer
S-1
docetaxel
phase III study
Lead sponsor: Japan Clinical Cancer Research Organization
Sponsor class: OTHER
Collaborators: name: Korean Cancer Study Group
First posted: 2006-02-07
Enrollment: 628
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: overall survival
timeFrame: median
Secondary outcomes:
measure: time-to-progression
timeFrame: From onset of regression to progression
measure: response rate
timeFrame: response during observation
measure: safety
timeFrame: side effects during observation
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosahi University Graduate School of Medicine
state: Aomori
city: Hirosaki
country: Japan
facility: Hirosaki Unuversity,School of Medicine
state: Aomori
city: Misawa
country: Japan
facility: Misawa City Hospital
state: Aomori
city: Matsuyama
country: Japan
facility: Matsuyama Simin Hospital
state: Ehime
city: Iizuka
country: Japan
facility: Iizuka Hospital
state: Fukuoka
city: Kitakyusyu
country: Japan
facility: Nippon Steel Yawata Memorial Hospital
state: Fukuoka
city: Kitakyusyu
country: Japan
facility: Universsity of Occupational and Environmental Health,Japan
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Ibi
country: Japan
facility: Ibi Kose Hospital
state: Gifu
city: Maehashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Oota
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Fukuyama
country: Japan
facility: Fukuyama City Hospital
state: Hiroshima
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center
state: Hiroshima
city: Asahikawa
country: Japan
facility: Asahikawa-Kosei General Hospital
state: Hokkaido
city: Asahikawa
country: Japan
facility: Asahikawa Medical College Hospital
state: Hokkaido
city: Hakodate
country: Japan
facility: Hakodate Goryoukaku Hopsital
state: Hokkaido
city: Kushiro
country: Japan
facility: Kushiro City General Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Itan
country: Japan
facility: Kinki Central Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Nishimiya
country: Japan
facility: Hyogo College Of Medicine
state: Hyogo
city: Hitachi
country: Japan
facility: Hitachi General Hospital
state: Ibaragi
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Kanazawa
country: Japan
facility: Kanazawa Medical School Hospital
state: Ishikawa
city: Kawakita
country: Japan
facility: Kanazawa Medical University Hospital
state: Ishikawa
city: Nanao
country: Japan
facility: Keiju Medical Center
state: Ishikawa
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Morioka
country: Japan
facility: Morioka Red Cross Hospital
state: Iwate
city: Isehara
country: Japan
facility: Tokai Medical University Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: St.Marianna University School of Medicine
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitasato University East Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Showa University Fujigaoka Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama Citizen's Municipal Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: St. Marianna University School of Medicine,Yokohama City Seibu Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Prefectural Cancer Center
state: Kanagawa
city: Yokohama
country: Japan
facility: Showa University Northern Yokohama Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku Rosai Hospital
state: Miyagi
city: Sendai
country: Japan
facility: Institute of Development,Aging and Cancer,Tohoku University
state: Miyagi
city: Nakano
country: Japan
facility: Hokushin Synthesis Hospital
state: Nagano
city: Oomura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
state: Nagasaki
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Maniwa
country: Japan
facility: Kaneda Hospital
state: Okayama
city: Chutougun
country: Japan
facility: Hospital, University of the Ryukyus
state: Okinawa
city: Izumisano
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Kimen
country: Japan
facility: Kimen Municipal Hospital
state: Osaka
city: Sakai
country: Japan
facility: Sakai Municipal Hospital
state: Osaka
city: Sayama
country: Japan
facility: Kinki Medical University Hospital
state: Osaka
city: Toyonaka
country: Japan
facility: Toyonaka Municipal Hospital
state: Osaka
city: Yao
country: Japan
facility: Yao Municipal Hospital
state: Osaka
city: Otsu
country: Japan
facility: Otsu Municipal Hospital
state: Shiga
city: Ritto
country: Japan
facility: Saiseikai Shiga Hospital
state: Shiga
city: Izumo
country: Japan
facility: Shimane University Faculty of Medicine
state: Shimane
city: Hyogo
country: Japan
facility: Takarazuka City Hospital
state: Takarazuka
city: Shimono
country: Japan
facility: Jichi Medical School Hospital
state: Tochigi
city: Shimotsuga
country: Japan
facility: Dokkyo University School of Medecine
state: Tochigi
city: Komatsushima
country: Japan
facility: Tokushima Red Cross Hospital
state: Tokushima
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University Hospital Faculty of Medicine
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Komagome Hospital
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Surugadai Nihon University Hospital
state: Tokyo
city: Hachioji
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Japan Clinical Cancer Research Organization
state: Tokyo
city: Koto-ku
country: Japan
facility: Showa University Toyosu Hospital
state: Tokyo
city: Meguro-ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University
state: Tokyo
city: Minato-ku
country: Japan
facility: International University of Health and Welfare Mita Hospital
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: International Medical Center of Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Social Insurange Central General Hospital
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Faculty of Medicine
state: Tottori
city: Takaoka
country: Japan
facility: Kouseiren Takaoka Hospital
state: Toyama
city: Kohfu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Aichi
country: Japan
facility: Aichi Medical University Hospital
city: Akita
country: Japan
facility: Akita University Hospital
city: Akita
country: Japan
facility: Nakadoori General Hospital
city: Aomori
country: Japan
facility: Aomori Prefectural Central Hospital
city: Chiba
country: Japan
facility: Department of frontier surgery Graduate school of medicine,Chiba University
city: Ehime
country: Japan
facility: Department of Organ kegulatory Surgery (First Department Surgery),Ehime University Graduate School of Medicine
city: Fukui
country: Japan
facility: Fukui Prefectural Hospital
city: Fukui
country: Japan
facility: Fukui Red Cross Hospital
city: Fukui
country: Japan
facility: Saiseikai Hospital
city: Fukuoka
country: Japan
facility: Saiseikai Fukuoka General Hospital
city: Fukuoka
country: Japan
facility: National Kyusyu Cancer Center
city: Fukuoka
country: Japan
facility: Kyusyu University Faculty of Medical Sciences
city: Fukuoka
country: Japan
facility: Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Gifu
country: Japan
facility: Gifu Municipal Hospital
city: Gifu
country: Japan
facility: Gifu University School of Medicine
city: Gifu
country: Japan
facility: Gifu Prefectural Gifu Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
city: Hiroshima
country: Japan
facility: Horoshima City Asa Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery
city: Kagoshima
country: Japan
facility: Department of surgical oncology and digestive surgery kagoshima university graduate school
city: Kochi
country: Japan
facility: Kochi Health Sciences Center
city: Kumamoto
country: Japan
facility: Kumamoto Medical University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Kyoto
country: Japan
facility: University Hospital,Kyoto Prefectural University of Medicien
city: Nagano
country: Japan
facility: Nagano Municipal Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Graduate School of Biomedical Sciences
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Niigata
country: Japan
facility: Niigata Prefectural Cancer Center
city: Oita
country: Japan
facility: Oita Prefectural Hospital
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka
country: Japan
facility: Osaka City University Graduate School of Medicine
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Saga
country: Japan
facility: Saga Medical School Hospital
city: Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital
Study officials:
affiliation: Surugadai Nihon University Hospital
name: Masashi Fujii, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.