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Gastric CancerPhase 3NCT00287768

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

A Phase 3 study testing docetaxel + S-1 and S-1 in people with Gastric Cancer, run by Japan Clinical Cancer Research Organization at 116 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Gastric Cancer
What is being tested?
docetaxel + S-1 and S-1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
628 participants
Where
116 sitesJapan
Study dates
Mar 2006to Oct 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

116 sites in 1 country.

116 sites in 1 country

Japan116 sites

  • Akita University Hospital

    Akita, Akita, 010-8543

  • Nakadoori General Hospital

    Akita, Akita, 010-8577

  • Aomori Prefectural Central Hospital

    Aomori, Aomori, 030-8553

  • Asahikawa-Kosei General Hospital

    Asahikawa, Hokkaido, 078-8211

  • Asahikawa Medical College Hospital

    Asahikawa, Hokkaido, 078-8510

  • Tokyo Medical and Dental University Hospital Faculty of Medicine

    Bunkyo-ku, Tokyo, 113-8519

  • Tokyo Metropolitan Komagome Hospital

    Bunkyo-ku, Tokyo, 113-8677

  • Department of frontier surgery Graduate school of medicine,Chiba University

    Chiba, Chiba, 260-8670

  • Surugadai Nihon University Hospital

    Chiyoda-ku, Tokyo, 101-8309

  • Hospital, University of the Ryukyus

    Chutougun, Okinawa, 903-0215

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

    Ehime, Ehime, 791-0295

  • Fukui Prefectural Hospital

    Fukui-shi, Fukui, 910-0846

  • Fukui Red Cross Hospital

    Fukui-shi, Fukui, 918-8501

  • Saiseikai Hospital

    Fukui-shi, Fukui, 918-8503

  • Saiseikai Fukuoka General Hospital

    Fukuoka, Fukuoka, 810-0001

  • National Kyusyu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Kyusyu University Faculty of Medical Sciences

    Fukuoka, Fukuoka, 812-8582

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

    Fukuoka, Fukuoka, 815-8588

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • Fukuyama City Hospital

    Fukuyama, Hiroshima, 721-8511

  • Gifu Municipal Hospital

    Gifu, Gifu, 500-8513

  • Gifu University School of Medicine

    Gifu, Gifu, 501-1193

  • Gifu Prefectural Gifu Hospital

    Gifu, Gifu, ５００-８７１７

  • Tokyo Medical University Hachioji Medical Center

    Hachiōji, Tokyo, 193-0998

  • Hakodate Goryoukaku Hopsital

    Hakodate, Hokkaido, 040-0001

  • Hirosahi University Graduate School of Medicine

    Hirosaki, Aomori, 036-8562

  • Hirosaki Unuversity,School of Medicine

    Hirosaki, Aomori, 036-8562

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    Hiroshima, Hiroshima, 730-8619

  • Horoshima City Asa Hospital

    Hiroshima, Hiroshima, 731-0293

  • Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery

    Hiroshima, Hiroshima, 734-8553

  • Hitachi General Hospital

    Hitachi, Ibaragi, MD

  • Takarazuka City Hospital

    Hyōgo, Takarazuka, 665-0827

  • Ibi Kose Hospital

    Ibi, Gifu, 501-0619

  • Iizuka Hospital

    Iizuka, Fukuoka, 820-8505

  • Tokai Medical University Hospital

    Isehara, Kanagawa, 259-1193

  • Teikyo University Hospital

    Itabashi-ku, Tokyo, 173-8606

  • Nihon University Itabashi Hospital

    Itabashi-ku, Tokyo, 173-8610

  • Kinki Central Hospital

    Itami, Hyōgo, 662-8533

  • Rinku General Medical Center

    Izumisano, Osaka, 598-0048

  • Shimane University Faculty of Medicine

    Izumo, Shimane, 693-8501

  • Department of surgical oncology and digestive surgery kagoshima university graduate school

    Kagoshima, Kagoshima-ken, 890-8520

  • Ishikawa Prefectural Central Hospital

    Kanazawa, Ishikawa-ken, 920-8530

  • Kanazawa Medical School Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Nara Medical University Hospital

    Kashihara, Nara, 634-8851

  • St.Marianna University School of Medicine

    Kawasaki, Kanagawa, 216-8511

  • Kimen Municipal Hospital

    Kimen, Osaka, 562-8562

  • Nippon Steel Yawata Memorial Hospital

    Kitakyushu, Fukuoka, 805-8508

  • Universsity of Occupational and Environmental Health,Japan

    Kitakyushu, Fukuoka, 807-8550

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Kochi Health Sciences Center

    Kochi, Kochi, 781-8555

  • Yamanashi Prefectural Central Hospital

    Kohfu, Yamanashi, 400-8506

  • Tokushima Red Cross Hospital

    Komatsushimachō, Tokushima, 773-8502

  • Cancer Institute Hospital

    Koto-ku, Tokyo, 135-8550

  • Japan Clinical Cancer Research Organization

    Koto-ku, Tokyo, 135-8550

  • Showa University Toyosu Hospital

    Koto-ku, Tokyo, 135-8577

  • Kumamoto Medical University Hospital

    Kumamoto, Kumamoto, MD

  • National Hospital Organization Kure Medical Center

    Kure, Hiroshima, 737-0023

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Kushiro City General Hospital

    Kushiro, Hokkaido, 085-0822

  • Kyoto University Hospital

    Kyoto, Kyoto, 506-8507

  • University Hospital,Kyoto Prefectural University of Medicien

    Kyoto, Kyoto, 602-8566

  • Gunma University Hospital

    Maehashi, Gunma, 371-0034

  • Kaneda Hospital

    Maniwa, Okayama-ken, 719-3105

  • Matsuyama Simin Hospital

    Matsuyama, Ehime, 790-0067

  • National Hospital Organization Tokyo Medical Center

    Meguro-ku, Tokyo, 152-0021

  • Toho University Ohashi Medical Center

    Meguro-ku, Tokyo, 153-8515

  • Toranomon Hospital

    Minato-ku, Tokyo, 105-8470

  • The Jikei University

    Minato-ku, Tokyo, 105-8471

  • International University of Health and Welfare Mita Hospital

    Minato-ku, Tokyo, 108-8329

  • Misawa City Hospital

    Misawa, Aomori, 033-0001

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505

  • Morioka Red Cross Hospital

    Morioka, Iwate, 020-8560

  • Nagano Municipal Hospital

    Nagano, Nagano, 381-0006

  • Nagasaki University Graduate School of Biomedical Sciences

    Nagasaki, Nagasaki, 852-850

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Nagoya, 460-0001

  • Kanazawa Medical University Hospital

    Nakajima, Ishikawa-ken, 920-0293

  • Hokushin Synthesis Hospital

    Nakano, Nagano, 383-8505

  • Keiju Medical Center

    Nanao, Ishikawa-ken, 926-8605

  • Niigata Prefectural Cancer Center

    Niigata, Niigata, 951-8566

  • Hyogo College Of Medicine

    Nishimiya, Hyōgo, 663-8501

  • Oita Prefectural Hospital

    Ōita, Oita Prefecture, 870-8511

  • Aichi Medical University Hospital

    Okazaki, Aichi-ken, 480-1195

  • National Hospital Organization Nagasaki Medical Center

    Oomura, Nagasaki, 856-8562

  • Gunma Prefectural Cancer Center

    Oota, Gunma, 373-8550

  • National Hospital Organization Osaka National Hospital

    Osaka, Osaka, 540-0006

  • Osaka City University Graduate School of Medicine

    Osaka, Osaka, 545-8585

  • Osaka General Medical Center

    Osaka, Osaka, 558-8558

  • Otsu Municipal Hospital

    Ōtsu, Shiga, 520-0804

  • Saiseikai Shiga Hospital

    Rittō, Shiga, 520-3046

  • Saga Medical School Hospital

    Saga, Saga-ken, 849-8501

  • Kitasato University East Hospital

    Sagamihara, Kanagawa, 228-8520

  • Sakai Municipal Hospital

    Sakai, Osaka, 590-0064

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543

  • Kinki Medical University Hospital

    Sayama, Osaka, 589-8511

  • Tohoku Rosai Hospital

    Sendai, Miyagi, 980-8574

  • Institute of Development,Aging and Cancer,Tohoku University

    Sendai, Miyagi, 980-8575

  • Jichi Medical School Hospital

    Shimono, Tochigi, 329-0498

  • Dokkyo University School of Medecine

    Shimotsuga, Tochigi, 321-0293

  • Showa University Hospital

    Shinagawa-ku, Tokyo, 142-8666

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582

  • International Medical Center of Japan

    Shinjuku-ku, Tokyo, 162-8655

  • Social Insurange Central General Hospital

    Shinjuku-ku, Tokyo, 169-0073

  • Kouseiren Takaoka Hospital

    Takaoka, Toyama, 933-8555

  • Toyonaka Municipal Hospital

    Toyonaka, Osaka, 560-8565

  • Yamagata Prefectural Central Hospital

    Yamagata, Yamagata, 990-2292

  • Yao Municipal Hospital

    Yao, Osaka, 581-0069

  • Showa University Fujigaoka Hospital

    Yokohama, Kanagawa, 227-8501

  • Yokohama Citizen's Municipal Hospital

    Yokohama, Kanagawa, 240-8550

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

    Yokohama, Kanagawa, 241-0811

  • Kanagawa Prefectural Cancer Center

    Yokohama, Kanagawa, 241-0815

  • Showa University Northern Yokohama Hospital

    Yokohama, Kanagawa, MD

  • Tottori University Faculty of Medicine

    Yonago, Tottori, 683-8504

Other trials in Japan

About this study

Official title: 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.

Read the 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
Being tested
docetaxel + S-1, S-1
Keywords
gastric cancer, advanced gastric cancer, S-1, docetaxel, phase III study
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • docetaxel + S-1Drug

    Also called taxotere, TS-1

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

  • S-1Drug

    Also called TS-1

    S-1 po days 1-28 every 6 weeks

Study groups in NCT00287768
Study groupRoleWhat they receive
1ExperimentalDocetaxel + S-1
Receives: Drug: docetaxel + S-1
2Active comparatorS-1
Receives: Drug: S-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: median

Secondary outcomes (3)

  1. time-to-progression

    Measured: From onset of regression to progression

  2. response rate

    Measured: response during observation

  3. safety

    Measured: side effects during observation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionSep 2008
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
628 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00287768
Sponsor's protocol ID
JACCRO GC-03
Status last verified
Jun 2011
First submitted
3 Feb 2006
Last updated
28 Jun 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38140879

  • 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.

    PubMed 24366758

  • 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.

    PubMed 18553228

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing docetaxel + S-1 and S-1 in people with Gastric Cancer, run by Japan Clinical Cancer Research Organization at 116 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: median). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00287768, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011; AzTrials last refreshed its copy on 6 Nov 2026.

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