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

This study has been completed.
Sponsor:
Collaborator:
Korean Cancer Study Group
Information provided by:
Japan Clinical Cancer Research Organization
ClinicalTrials.gov Identifier:
NCT00287768
First received: February 3, 2006
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: docetaxel + S-1
Drug: S-1
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Japan Clinical Cancer Research Organization:

Primary Outcome Measures:
  • overall survival [ Time Frame: median ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time-to-progression [ Time Frame: From onset of regression to progression ] [ Designated as safety issue: No ]
  • response rate [ Time Frame: response during observation ] [ Designated as safety issue: No ]
  • safety [ Time Frame: side effects during observation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 628
Study Start Date: March 2006
Study Completion Date: October 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Docetaxel + S-1
Drug: docetaxel + S-1
Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks
Other Names:
  • taxotere
  • TS-1
Active Comparator: 2
S-1
Drug: S-1
S-1 po days 1-28 every 6 weeks
Other Name: TS-1

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

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287768

  Hide Study Locations
Locations
Japan
Aichi Cancer Center
Nagoya, Aichi, Japan, 464-8681
Hirosahi University Graduate School of Medicine
Hirosaki, Aomori, Japan, 036-8562
Hirosaki Unuversity,School of Medicine
Hirosaki, Aomori, Japan, 036-8562
Misawa City Hospital
Misawa, Aomori, Japan, 033-0001
Matsuyama Simin Hospital
Matsuyama, Ehime, Japan, 790-0067
Iizuka Hospital
Iizuka, Fukuoka, Japan, 820-8505
Nippon Steel Yawata Memorial Hospital
Kitakyusyu, Fukuoka, Japan, 805-8508
Universsity of Occupational and Environmental Health,Japan
Kitakyusyu, Fukuoka, Japan, 807-8550
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
Ibi Kose Hospital
Ibi, Gifu, Japan, 501-0619
Gunma University Hospital
Maehashi, Gunma, Japan, 371-0034
Gunma Prefectural Cancer Center
Oota, Gunma, Japan, 373-8550
Fukuyama City Hospital
Fukuyama, Hiroshima, Japan, 721-8511
National Hospital Organization Kure Medical Center
Kure, Hiroshima, Japan, 737-0023
Asahikawa-Kosei General Hospital
Asahikawa, Hokkaido, Japan, 078-8211
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, Japan, 078-8510
Hakodate Goryoukaku Hopsital
Hakodate, Hokkaido, Japan, 040-0001
Kushiro City General Hospital
Kushiro, Hokkaido, Japan, 085-0822
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan, 060-8543
Kinki Central Hospital
Itan, Hyogo, Japan, 662-8533
Kobe University Hospital
Kobe, Hyogo, Japan, 650-0017
Hyogo College Of Medicine
Nishimiya, Hyogo, Japan, 663-8501
Hitachi General Hospital
Hitachi, Ibaragi, Japan, MD
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa, Japan, 920-8530
Kanazawa Medical School Hospital
Kanazawa, Ishikawa, Japan, 920-8641
Kanazawa Medical University Hospital
Kawakita, Ishikawa, Japan, 920-0293
Keiju Medical Center
Nanao, Ishikawa, Japan, 926-8605
Iwate Medical University Hospital
Morioka, Iwate, Japan, 020-8505
Morioka Red Cross Hospital
Morioka, Iwate, Japan, 020-8560
Tokai Medical University Hospital
Isehara, Kanagawa, Japan, 259-1193
St.Marianna University School of Medicine
Kawasaki, Kanagawa, Japan, 216-8511
Kitasato University East Hospital
Sagamihara, Kanagawa, Japan, 228-8520
St. Marianna University School of Medicine,Yokohama City Seibu Hospital
Yokohama, Kanagawa, Japan, 241-0811
Showa University Fujigaoka Hospital
Yokohama, Kanagawa, Japan, 227-8501
Kanagawa Prefectural Cancer Center
Yokohama, Kanagawa, Japan, 241-0815
Yokohama Citizen's Municipal Hospital
Yokohama, Kanagawa, Japan, 240-8550
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, Japan, MD
Tohoku Rosai Hospital
Sendai, Miyagi, Japan, 980-8574
Institute of Development,Aging and Cancer,Tohoku University
Sendai, Miyagi, Japan, 980-8575
Hokushin Synthesis Hospital
Nakano, Nagano, Japan, 383-8505
National Hospital Organization Nagasaki Medical Center
Oomura, Nagasaki, Japan, 856-8562
Nara Medical University Hospital
Kashihara, Nara, Japan, 634-8851
Kaneda Hospital
Maniwa, Okayama, Japan, 719-3105
Hospital, University of the Ryukyus
Chutougun, Okinawa, Japan, 903-0215
Rinku General Medical Center
Izumisano, Osaka, Japan, 598-0048
Kimen Municipal Hospital
Kimen, Osaka, Japan, 562-8562
Sakai Municipal Hospital
Sakai, Osaka, Japan, 590-0064
Kinki Medical University Hospital
Sayama, Osaka, Japan, 589-8511
Toyonaka Municipal Hospital
Toyonaka, Osaka, Japan, 560-8565
Yao Municipal Hospital
Yao, Osaka, Japan, 581-0069
Otsu Municipal Hospital
Otsu, Shiga, Japan, 520-0804
Saiseikai Shiga Hospital
Ritto, Shiga, Japan, 520-3046
Shimane University Faculty of Medicine
Izumo, Shimane, Japan, 693-8501
Takarazuka City Hospital
Hyogo, Takarazuka, Japan, 665-0827
Jichi Medical School Hospital
Shimono, Tochigi, Japan, 329-0498
Dokkyo University School of Medecine
Shimotsuga, Tochigi, Japan, 321-0293
Tokushima Red Cross Hospital
Komatsushima, Tokushima, Japan, 773-8502
Tokyo Medical and Dental University Hospital Faculty of Medicine
Bunkyo-ku, Tokyo, Japan, 113-8519
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku, Tokyo, Japan, 113-8677
Surugadai Nihon University Hospital
Chiyoda-ku, Tokyo, Japan, 101-8309
Tokyo Medical University Hachioji Medical Center
Hachioji, Tokyo, Japan, 193-0998
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan, 173-8606
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan, 173-8610
Cancer Institute Hospital
Koto-ku, Tokyo, Japan, 135-8550
Showa University Toyosu Hospital
Koto-ku, Tokyo, Japan, 135-8577
Japan Clinical Cancer Research Organization
Koto-ku, Tokyo, Japan, 135-8550
Toho University Ohashi Medical Center
Meguro-ku, Tokyo, Japan, 153-8515
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, Japan, 152-0021
The Jikei University
Minato-ku, Tokyo, Japan, 105-8471
Toranomon Hospital
Minato-ku, Tokyo, Japan, 105-8470
International University of Health and Welfare Mita Hospital
Minato-ku, Tokyo, Japan, 108-8329
Kyorin University Hospital
Mitaka, Tokyo, Japan, 181-8611
Showa University Hospital
Shinagawa-ku, Tokyo, Japan, 142-8666
Keio University Hospital
Shinjuku-ku, Tokyo, Japan, 160-8582
Social Insurange Central General Hospital
Shinjuku-ku, Tokyo, Japan, 169-0073
International Medical Center of Japan
Shinjuku-ku, Tokyo, Japan, 162-8655
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 160-0023
Tottori University Faculty of Medicine
Yonago, Tottori, Japan, 683-8504
Kouseiren Takaoka Hospital
Takaoka, Toyama, Japan, 933-8555
Yamanashi Prefectural Central Hospital
Kohfu, Yamanashi, Japan, 400-8506
Aichi Medical University Hospital
Aichi, Japan, 480-1195
Akita University Hospital
Akita, Japan, 010-8543
Nakadoori General Hospital
Akita, Japan, 010-8577
Aomori Prefectural Central Hospital
Aomori, Japan, 030-8553
Department of frontier surgery Graduate school of medicine,Chiba University
Chiba, Japan, 260-8670
Department of Organ kegulatory Surgery (First Department Surgery),Ehime University Graduate School of Medicine
Ehime, Japan, 791-0295
Fukui Prefectural Hospital
Fukui, Japan, 910-0846
Fukui Red Cross Hospital
Fukui, Japan, 918-8501
Saiseikai Hospital
Fukui, Japan, 918-8503
Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuoka, Japan, 815-8588
Saiseikai Fukuoka General Hospital
Fukuoka, Japan, 810-0001
National Kyusyu Cancer Center
Fukuoka, Japan, 811-1395
Kyusyu University Faculty of Medical Sciences
Fukuoka, Japan, 812-8582
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Gifu University School of Medicine
Gifu, Japan, 501-1193
Gifu Municipal Hospital
Gifu, Japan, 500-8513
Gifu Prefectural Gifu Hospital
Gifu, Japan, 500-8717
Horoshima City Asa Hospital
Hiroshima, Japan, 731-0293
Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery
Hiroshima, Japan, 734-8553
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Japan, 730-8619
Department of surgical oncology and digestive surgery kagoshima university graduate school
Kagoshima, Japan, 890-8520
Kochi Health Sciences Center
Kochi, Japan, 781-8555
Kumamoto Medical University Hospital
Kumamoto, Japan, MD
Kyoto University Hospital
Kyoto, Japan, 506-8507
University Hospital,Kyoto Prefectural University of Medicien
Kyoto, Japan, 602-8566
Nagano Municipal Hospital
Nagano, Japan, 381-0006
Nagasaki University Graduate School of Biomedical Sciences
Nagasaki, Japan, 852-850
National Hospital Organization Nagoya Medical Center
Nagoya, Japan, 460-0001
Niigata Prefectural Cancer Center
Niigata, Japan, 951-8566
Oita Prefectural Hospital
Oita, Japan, 870-8511
Osaka City University Graduate School of Medicine
Osaka, Japan, 545-8585
Osaka General Medical Center
Osaka, Japan, 558-8558
National Hospital Organization Osaka National Hospital
Osaka, Japan, 540-0006
Saga Medical School Hospital
Saga, Japan, 849-8501
Yamagata Prefectural Central Hospital
Yamagata, Japan, 990-2292
Sponsors and Collaborators
Japan Clinical Cancer Research Organization
Korean Cancer Study Group
Investigators
Principal Investigator: Masashi Fujii, MD PhD Surugadai Nihon University Hospital
  More Information

No publications provided by Japan Clinical Cancer Research Organization

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Masashi Fujii / Associate Professor, Department of Surgery, Surugadai Nippon University
ClinicalTrials.gov Identifier: NCT00287768     History of Changes
Other Study ID Numbers: JACCRO GC-03
Study First Received: February 3, 2006
Last Updated: June 27, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Cancer Research Organization:
gastric cancer
advanced gastric cancer
S-1
docetaxel
phase III study

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014