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

NCT ID: NCT00287768

Last Updated: 2011-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 628 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2010-10-31

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).

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Docetaxel + S-1

Group Type: EXPERIMENTAL

docetaxel + S-1

Intervention Type: DRUG

Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks

2

S-1

Group Type: ACTIVE_COMPARATOR

S-1

Intervention Type: DRUG

S-1 po days 1-28 every 6 weeks

Interventions

docetaxel + S-1

Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks

Intervention Type: DRUG

S-1

S-1 po days 1-28 every 6 weeks

Intervention Type: DRUG

Other Intervention Names

taxotere; TS-1; TS-1

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korean Cancer Study Group

OTHER

Sponsor Role: collaborator

Japan Clinical Cancer Research Organization

OTHER

Sponsor Role: lead

Responsible Party

Department of Surgery, Surugadai Nippon University

Principal Investigators

Masashi Fujii, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Surugadai Nihon University Hospital

Locations

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

Aichi Medical University Hospital

Okazaki, Aichi-ken, Japan

Akita University Hospital

Akita, Akita, Japan

Nakadoori General Hospital

Akita, Akita, Japan

Aomori Prefectural Central Hospital

Aomori, Aomori, Japan

Hirosahi University Graduate School of Medicine

Hirosaki, Aomori, Japan

Hirosaki Unuversity,School of Medicine

Hirosaki, Aomori, Japan

Misawa City Hospital

Misawa, Aomori, Japan

Department of frontier surgery Graduate school of medicine,Chiba University

Chiba, Chiba, Japan

Department of Organ kegulatory Surgery (First Department Surgery),Ehime University Graduate School of Medicine

Ehime, Ehime, Japan

Matsuyama Simin Hospital

Matsuyama, Ehime, Japan

Fukui Prefectural Hospital

Fukui-shi, Fukui, Japan

Fukui Red Cross Hospital

Fukui-shi, Fukui, Japan

Saiseikai Hospital

Fukui-shi, Fukui, Japan

Saiseikai Fukuoka General Hospital

Fukuoka, Fukuoka, Japan

National Kyusyu Cancer Center

Fukuoka, Fukuoka, Japan

Kyusyu University Faculty of Medical Sciences

Fukuoka, Fukuoka, Japan

Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers

Fukuoka, Fukuoka, Japan

Iizuka Hospital

Iizuka, Fukuoka, Japan

Nippon Steel Yawata Memorial Hospital

Kitakyushu, Fukuoka, Japan

Universsity of Occupational and Environmental Health,Japan

Kitakyushu, Fukuoka, Japan

Kurume University Hospital

Kurume, Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Gifu Municipal Hospital

Gifu, Gifu, Japan

Gifu University School of Medicine

Gifu, Gifu, Japan

Gifu Prefectural Gifu Hospital

Gifu, Gifu, Japan

Ibi Kose Hospital

Ibi, Gifu, Japan

Gunma University Hospital

Maehashi, Gunma, Japan

Gunma Prefectural Cancer Center

Oota, Gunma, Japan

Fukuyama City Hospital

Fukuyama, Hiroshima, Japan

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, Hiroshima, Japan

Horoshima City Asa Hospital

Hiroshima, Hiroshima, Japan

Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery

Hiroshima, Hiroshima, Japan

National Hospital Organization Kure Medical Center

Kure, Hiroshima, Japan

Asahikawa-Kosei General Hospital

Asahikawa, Hokkaido, Japan

Asahikawa Medical College Hospital

Asahikawa, Hokkaido, Japan

Hakodate Goryoukaku Hopsital

Hakodate, Hokkaido, Japan

Kushiro City General Hospital

Kushiro, Hokkaido, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Kinki Central Hospital

Itami, Hyōgo, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Hyogo College Of Medicine

Nishimiya, Hyōgo, Japan

Hitachi General Hospital

Hitachi, Ibaragi, Japan

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, Japan

Kanazawa Medical School Hospital

Kanazawa, Ishikawa-ken, Japan

Kanazawa Medical University Hospital

Nakajima, Ishikawa-ken, Japan

Keiju Medical Center

Nanao, Ishikawa-ken, Japan

Iwate Medical University Hospital

Morioka, Iwate, Japan

Morioka Red Cross Hospital

Morioka, Iwate, Japan

Department of surgical oncology and digestive surgery kagoshima university graduate school

Kagoshima, Kagoshima-ken, Japan

Tokai Medical University Hospital

Isehara, Kanagawa, Japan

St.Marianna University School of Medicine

Kawasaki, Kanagawa, Japan

Kitasato University East Hospital

Sagamihara, Kanagawa, Japan

Showa University Fujigaoka Hospital

Yokohama, Kanagawa, Japan

Yokohama Citizen's Municipal Hospital

Yokohama, Kanagawa, Japan

St. Marianna University School of Medicine,Yokohama City Seibu Hospital

Yokohama, Kanagawa, Japan

Kanagawa Prefectural Cancer Center

Yokohama, Kanagawa, Japan

Showa University Northern Yokohama Hospital

Yokohama, Kanagawa, Japan

Kochi Health Sciences Center

Kochi, Kochi, Japan

Kumamoto Medical University Hospital

Kumamoto, Kumamoto, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

University Hospital,Kyoto Prefectural University of Medicien

Kyoto, Kyoto, Japan

Tohoku Rosai Hospital

Sendai, Miyagi, Japan

Institute of Development,Aging and Cancer,Tohoku University

Sendai, Miyagi, Japan

Nagano Municipal Hospital

Nagano, Nagano, Japan

Hokushin Synthesis Hospital

Nakano, Nagano, Japan

Nagasaki University Graduate School of Biomedical Sciences

Nagasaki, Nagasaki, Japan

National Hospital Organization Nagasaki Medical Center

Oomura, Nagasaki, Japan

National Hospital Organization Nagoya Medical Center

Nagoya, Nagoya, Japan

Nara Medical University Hospital

Kashihara, Nara, Japan

Niigata Prefectural Cancer Center

Niigata, Niigata, Japan

Oita Prefectural Hospital

Ōita, Oita Prefecture, Japan

Kaneda Hospital

Maniwa, Okayama-ken, Japan

Hospital, University of the Ryukyus

Chutougun, Okinawa, Japan

Rinku General Medical Center

Izumisano, Osaka, Japan

Kimen Municipal Hospital

Kimen, Osaka, Japan

National Hospital Organization Osaka National Hospital

Osaka, Osaka, Japan

Osaka City University Graduate School of Medicine

Osaka, Osaka, Japan

Osaka General Medical Center

Osaka, Osaka, Japan

Sakai Municipal Hospital

Sakai, Osaka, Japan

Kinki Medical University Hospital

Sayama, Osaka, Japan

Toyonaka Municipal Hospital

Toyonaka, Osaka, Japan

Yao Municipal Hospital

Yao, Osaka, Japan

Saga Medical School Hospital

Saga, Saga-ken, Japan

Otsu Municipal Hospital

Ōtsu, Shiga, Japan

Saiseikai Shiga Hospital

Rittō, Shiga, Japan

Shimane University Faculty of Medicine

Izumo, Shimane, Japan

Takarazuka City Hospital

Hyōgo, Takarazuka, Japan

Jichi Medical School Hospital

Shimono, Tochigi, Japan

Dokkyo University School of Medecine

Shimotsuga, Tochigi, Japan

Tokushima Red Cross Hospital

Komatsushimachō, Tokushima, Japan

Tokyo Medical and Dental University Hospital Faculty of Medicine

Bunkyo-ku, Tokyo, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyo-ku, Tokyo, Japan

Surugadai Nihon University Hospital

Chiyoda-ku, Tokyo, Japan

Tokyo Medical University Hachioji Medical Center

Hachiōji, Tokyo, Japan

Teikyo University Hospital

Itabashi-ku, Tokyo, Japan

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, 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

National Hospital Organization Tokyo Medical Center

Meguro-ku, Tokyo, Japan

Toho University Ohashi Medical Center

Meguro-ku, Tokyo, Japan

Toranomon Hospital

Minato-ku, Tokyo, Japan

The Jikei University

Minato-ku, Tokyo, Japan

International University of Health and Welfare Mita Hospital

Minato-ku, Tokyo, Japan

Kyorin University Hospital

Mitaka, Tokyo, Japan

Showa University Hospital

Shinagawa-ku, Tokyo, Japan

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

International Medical Center of Japan

Shinjuku-ku, Tokyo, Japan

Social Insurange Central General Hospital

Shinjuku-ku, Tokyo, Japan

Tottori University Faculty of Medicine

Yonago, Tottori, Japan

Kouseiren Takaoka Hospital

Takaoka, Toyama, Japan

Yamagata Prefectural Central Hospital

Yamagata, Yamagata, Japan

Yamanashi Prefectural Central Hospital

Kohfu, Yamanashi, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 38140879 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24366758 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18553228 (View on PubMed)

Other Identifiers

JACCRO GC-03

Identifier Type: -

Identifier Source: org_study_id