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Gastric NeoplasmPhase 3NCT00252161

A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer

A Phase 3 study testing Gastrectomy with more than D2 dissection and Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy in people with Gastric Neoplasm, run by Haruhiko Fukuda at 35 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

The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Gastric Neoplasm
What is being tested?
Gastrectomy with more than D2 dissection and Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
35 sitesJapan
Study dates
Nov 2005to Apr 2015
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

  • histologically proven adenocarcinoma of stomach
  • Borrmann type 4 or large (>=8 cm) type 3
  • no evidence of distant metastasis including liver(M0)
  • no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2)
  • no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with laparoscopic confirmation
  • no involvement of the esophagus with > 3cm
Show all 14Show fewer
  • an age of 20-75 years
  • an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • no prior chemotherapy, radiotherapy for any malignancy
  • no prior surgery for gastric cancer except for endoscopic membrane resection (EMR)
  • no breeding from primary tumor or gastrointestinal stenosis
  • sufficient oral intake
  • adequate organ function
  • written informed consent

Who cannot join

  • synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
  • pregnant or breast-feeding women
  • severe mental disease
  • systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
  • other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
  • myocardial infarction within six disease-free months

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

Japan35 sites

  • Tokyo Metropolitan Komagome Hospital

    Bunkyo-ku,Honkomagome,3-18-22, Tokyo, 113-8677

  • Tokyo Medical and Dental University Hospital

    Bunkyo-ku,Yushima,1-5-45, Tokyo, 113-8519

  • National Cancer Center Hospital

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

  • Gifu Municipal Hospital

    Gifu,Kashima-cho,7-1, Gifu, 500-8323

  • Hiroshima City Hospital

    Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, 730-8518

  • Itami City Hospital

    Itami,Koyaike,1-100, Hyōgo, 664-8540

  • Kagoshima University,Faculty of Medicine

    Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, 890-8520

  • Kyoto Second Red Cross Hospital

    Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, 602-8026

  • National Cancer Center Hospital East

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

  • Saitama Cancer Center

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

  • Cancer Institute Hospital

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

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama,Horinouchi,13, Ehime, 790-0007

  • Iwate Medical University

    Morioka,Uchimaru,19-1, Iwate, 020-8505

  • Nagaoka Chuo General Hospital

    Nagaoka,Kawasaki,2041, Niigata, 940-8653

  • Aichi Cancer Center Hospital

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

  • Miyagi Cancer Center

    Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, 981-1293

  • Niigata Cancer Center Hospital

    Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566

  • Oita University Fuculty of Medicine

    Oita,Hasama-machi,Oogaoka,1-1, Oita Prefecture, 879-5593

  • Kinki University School of Medicine

    Osaka-Sayama,Ohno-higashi,377-2, Osaka, 589-8511

  • Osaka National Hospital

    Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, 540-0006

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511

  • Sakai Municipal Hospital

    Sakai,Minamiyasuicho,1-1-1, Osaka, 590-0064

  • National Hospital Organization, Sendai Medical Center

    Sendai,Miyagino-ku,Miyagino,2-8-8, Miyagi, 983-8520

  • International Medical Center of Japan

    Shinjuku-ku,Toyama,1-21-1, Tokyo, 162-8655

  • Shizuoka General Hospital

    Shizuoka,Aoi-ku,Kitaando,4-27-1, Shizuoka, 420-8527

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida-ku,Koutoubashi,4-23-15, Tokyo, 130-8575

  • Osaka Medical College

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

  • National Defense Medical College

    Tokorozawa,Namiki,3-2, Saitama, 359-8513

  • Toyama Prefectural Central Hospital

    Toyama,nishinagae,2-2-78, Toyama, 930-8550

  • Fujita Health University

    Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, 470-1192

  • Toyonaka Municipal Hospital

    Toyonaka,Shibaharacho,4-14-1, Osaka, 560-0055

  • Tsubame Rosai Hospital

    Tsubame,Sawatari,633, Niigata, 959-1228

  • Wakayama Medical University, School of Medicine

    Wakayama,Kimiidera,811-1, Wakayama, 641-8510

  • Yamagata Prefectural Central Hospital

    Yamagata,Aoyagi,1800, Yamagata, 990-2292

  • Kanagawa Cancer Center

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

Other trials in Japan

About this study

Official title: Randomized Phase III Trial of Surgery Plus Neoadjuvant TS-1 and Cisplatin Compared With Surgery Alone for Type 4 and Large Type 3 Gastric Cancer: Japan Clinical Oncology Group Study (JCOG 0501)

The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone.

Read the detailed description

A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3 gastric cancer.A total of 300 patients will be accrued for this study from 35 institutions within five years. The primary endpoint is overall survival. The secondary endpoints are progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events.

Being tested
Gastrectomy with more than D2 dissection, Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Keywords
Neoadjuvant Therapy, Stomach Neoplasms, Cisplatin, S-1(combination)
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Gastrectomy with more than D2 dissectionProcedure or surgery

    Gastrectomy with more than D2 dissection

  • Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomyDrug

    Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy

Study groups in NCT00252161
Study groupRoleWhat they receive
1Active comparatorProcedure/Surgery: Gastrectomy with more than D2 dissection
Receives: Procedure: Gastrectomy with more than D2 dissection
2ExperimentalDrug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Receives: Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy

What is being measured

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

  1. overall survival

    Measured: during the study conduct

Secondary outcomes (5)

  1. progression free survival (PFS)

    Measured: during the study conduct

  2. response rate

    Measured: during the study conduct

  3. proportion of protocol achievement

    Measured: during the study conduct

  4. proportion of curative resection

    Measured: during the study conduct

  5. adverse events

    Measured: during the study conduct

Timeline

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

  1. First posted11 Nov 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionApr 2015
  4. Study completionApr 2015

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
316 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00252161
Sponsor's protocol ID
JCOG0501
Other IDs
C000000279
Status last verified
Sep 2016
First submitted
10 Nov 2005
Last updated
22 Sep 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gastrectomy with more than D2 dissection and Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy in people with Gastric Neoplasm, run by Haruhiko Fukuda at 35 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 14 inclusion and 6 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 22 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 35 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: during the study conduct). 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 NCT00252161.

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 22 Sep 2016.

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