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

Gastric Cancer Clinical Trial

Official title:

A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287768
• Other study ID #: JACCRO GC-03
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2006
• Last updated: June 27, 2011
• Start date: March 2006
• Est. completion date: October 2010

Study information

• Verified date: June 2011
• Source: Japan Clinical Cancer Research Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: October 2010
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• docetaxel + S-1
Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks
• S-1
S-1 po days 1-28 every 6 weeks

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Cancer Research Organization	Korean Cancer Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		median	No
Secondary	time-to-progression		From onset of regression to progression	No
Secondary	response rate		response during observation	No
Secondary	safety		side effects during observation	Yes