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Gastric CancerPhase 3NCT00142350

A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer

A Phase 3 study testing continuous infusion of 5-fluorouracil, combination of irinotecan and cisplatin and oral administration of S-1 in people with Gastric Cancer, run by Japan Clinical Oncology Group at 34 sites in Japan.

Completed

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

Official record
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Trial summary

To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
continuous infusion of 5-fluorouracil, combination of irinotecan and cisplatin and oral administration of S-1
How many people
690 participants
Where
34 sitesJapan
Study dates
Nov 2000to Jan 2007
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • unresectable or recurrent histologically proved gastric cancer
  • adequate oral intake
  • age 20 or older and 75 or younger
  • Performance Status (ECOG):0, 1, 2
  • measurable or unmeasurable lesions
  • preserved organ functions
Show all 9Show fewer
  • no severe medical condition
  • no prior chemotherapy for gastric cancer
  • written informed consent

Who cannot join

  • patient with marked infection or inflammation
  • patient with severe peritoneal metastasis
  • patient with massive pleural effusion
  • patient with metastasis to CNS
  • patient with diarrhea 4 or more times per day
  • patient severe medical condition
Show all 10Show fewer
  • patient with other concurrent malignancy affecting on survival or adverse events
  • pregnant or nursing patient or with intent to bear baby
  • patient evaluated to be inadequate by a attending doctor
  • patient requiring nutritional support

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

Japan34 sites

  • Hyogo Medical Center for Adults

    Akashi,Kitaouji-cho,13-70, Hyōgo, 673-8558

  • Chiba Cancer Center Hospital

    Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, 260-8717

  • National Cancer Center Hospital

    Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045

  • Kyushu University Hospital

    Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582

  • National Kyushu Cancer Center

    Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, 811-1395

  • Aomori Prefectural Central Hospital

    Higashitsukurimiti,2-1-1,Aomori, Aomori, 030-0911

  • Asahi General Hospital

    I-1326,Asahi, Chiba, 289-2511

  • Saitama Medical School Hospital

    Iruma-gun,Moroyama-machi,Morohongo,38, Saitama, 350-0495

  • National Cancer Center Hospital East

    Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577

  • Federation of national public service personnel mutual aid associations Tonan Hospital

    Kita 1 Nishi 6,Chuo-ku,Sapporo, Hokkaido, 060-0001

  • Saitama Cancer Center

    Kita-adachi,Ina,Komuro,818, Saitama, 362-0806

  • Kobe University Graduate School of Medicine

    Kobe,Chuo-ku,Kusunoki-cho,7-5-2, Hyōgo, 650-0017

  • Kochi Health Science Center

    Kochi,Ike,2125-1, Kochi, 781-8555

  • Cancer Institute Hospital

    Koto-ku,Ariake,3-10-6, Tokyo, 135-8550

  • Kumamoto Regional Medical Center Hospital

    Kumamoto,Honjo,5-16-10, Kumamoto, 860-0811

  • Kyoto University Hospital

    Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, 606-8507

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama,Horinouchi,13, Ehime, 790-0007

  • Iwate Prefectural Central Hospital

    Morioka,Ueda,1-4-1, Iwate, 020-0066

  • Aichi Cancer Center Hospital

    Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681

  • Nagoya Medical Center

    Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi-ken, 460-0001

  • Ibaraki Kenritsu Chuo Hospital & Cancer Center

    Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, 309-1793

  • Hokkaido University Hospital

    North-14 West-5 Kita-ku,Sapporo, Hokkaido, 060-8648

  • Aichi Cancer Center,Aichi Hospital

    Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, 444-0011

  • Kitasato University East Hospital

    Sagamihara,Asamizodai,2-1-1, Kanagawa, 228-8520

  • Saku Central Hospital

    Saku,Usuda,197, Nagano, 384-0301

  • Tohoku University Hospital

    Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-8574

  • Showa University School of Medicine

    Shinagawa-ku,Hatanodai,1-5-8, Tokyo, 142-8666

  • Div. of Gastrointestinal Oncology, Shizuoka Cancer Center

    Sunto-gun, Nagaizumi-cho, Shimonagakubo,1007, Shizuoka, 411-8777

  • Osaka Medical College

    Takatsuki,Daigakucho,2-7, Osaka, 569-0801

  • Tochigi Cancer Center

    Utsunomiya,Yohnan,4-9-13, Tochigi, 320-0834

  • Yamagata Prefectural Central Hospital

    Yamagata,Aoyagi,1800, Yamagata, 990-2292

  • Kanagawa Cancer Center

    Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, 241-0815

  • Yokohama Mucipical Citizen's Hospital

    Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, 240-8555

  • Yokohama City University Medical Center

    Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, 232-0024

Other trials in Japan

About this study

Official title: Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)

To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer

Read the detailed description

From the results of our previous phase III study (JCOG9205), continuous infusion of 5-fluorouracil has remained to be a control arm of this study. This study investigates the superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall survival, and the planned number of enrolled patients is 690 (230/arm).

Conditions
Gastric Cancer
Being tested
continuous infusion of 5-fluorouracil, combination of irinotecan and cisplatin, oral administration of S-1
Keywords
gastric cancer, 5-fluorouracil, irinotecan, cisplatin, S-1, advanced or recurrent gastric cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • continuous infusion of 5-fluorouracilDrug

  • combination of irinotecan and cisplatinDrug

  • oral administration of S-1Drug

What is being measured

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

  1. overall survival

Secondary outcomes (4)

  1. time to treatment failure

  2. incidences of adverse events

  3. response rate

  4. non-hospitalized survival

Timeline

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

  1. First posted2 Sep 2005 (estimated)
  2. Study startNov 2000
  3. Study completionJan 2007

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
690 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00142350
Sponsor's protocol ID
JCOG9912
Other IDs
C000000062
Status last verified
Sep 2016
First submitted
1 Sep 2005
Last updated
12 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Kurokawa Y, Boku N, Yamaguchi T, Ohtsu A, Mizusawa J, Nakamura K, Fukuda H. Inter-institutional heterogeneity in outcomes of chemotherapy for metastatic gastric cancer: correlative study in the JCOG9912 phase III trial. ESMO Open. 2016 Feb 8;1(1):e000031. doi: 10.1136/esmoopen-2015-000031. eCollection 2016.

    PubMed 27843586

  • Takahari D, Boku N, Mizusawa J, Takashima A, Yamada Y, Yoshino T, Yamazaki K, Koizumi W, Fukase K, Yamaguchi K, Goto M, Nishina T, Tamura T, Tsuji A, Ohtsu A. Determination of prognostic factors in Japanese patients with advanced gastric cancer using the data from a randomized controlled trial, Japan clinical oncology group 9912. Oncologist. 2014 Apr;19(4):358-66. doi: 10.1634/theoncologist.2013-0306. Epub 2014 Mar 25.

    PubMed 24668328

  • Boku N, Yamamoto S, Fukuda H, Shirao K, Doi T, Sawaki A, Koizumi W, Saito H, Yamaguchi K, Takiuchi H, Nasu J, Ohtsu A; Gastrointestinal Oncology Study Group of the Japan Clinical Oncology Group. Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. Lancet Oncol. 2009 Nov;10(11):1063-9. doi: 10.1016/S1470-2045(09)70259-1. Epub 2009 Oct 7.

    PubMed 19818685

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing continuous infusion of 5-fluorouracil, combination of irinotecan and cisplatin and oral administration of S-1 in people with Gastric Cancer, run by Japan Clinical Oncology Group at 34 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 9 inclusion and 10 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 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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. 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 NCT00142350, 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 12 Sep 2016.

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