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

June 27, 2011 updated by: Japan Clinical Cancer Research Organization

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

628

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
S-1
Drug: S-1
S-1 po days 1-28 every 6 weeks
Other Names:
  • TS-1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: median
median

Secondary Outcome Measures

Outcome Measure
Time Frame
time-to-progression
Time Frame: From onset of regression to progression
From onset of regression to progression
response rate
Time Frame: response during observation
response during observation
safety
Time Frame: side effects during observation
side effects during observation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Clinical Cancer Research Organization

Collaborators

Korean Cancer Study Group

Investigators

  • Principal Investigator: Masashi Fujii, MD PhD, Surugadai Nihon university hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 3, 2006

First Submitted That Met QC Criteria

February 3, 2006

First Posted (Estimate)

February 7, 2006

Study Record Updates

Last Update Posted (Estimate)

June 28, 2011

Last Update Submitted That Met QC Criteria

June 27, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JACCRO GC-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on docetaxel + S-1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe