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Gastric CancerPhase 3NCT00216034

Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK

A Phase 3 study testing Tegafur-gimeracil-oteracil potassium (TS-1) and Krestin (PSK) in people with Gastric Cancer, run by Hokuriku-Kinki Immunochemotherapy Study Group at 42 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

A randomized controlled study is conducted on patients with resected gastric cancer assigned to postoperative adjuvant therapy of TS-1 alone or PSK combined with TS-1, with the objective to examine or validate the outcome, QOL and prognostic factors (host and tumor factors), and explore the factors enhancing the… Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Gastric Cancer
What is being tested?
Tegafur-gimeracil-oteracil potassium (TS-1) and Krestin (PSK)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
42 sitesJapan
Study dates
Mar 2005to Feb 2016
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with microscopic stage II or IIIA resectable gastric cancer
  • Patients who have not received preoperative cancer therapy (radiotherapy, chemotherapy or immunotherapy)
  • Patients with serum immunosuppressive acidic protein (IAP) measured within 2 weeks before surgery
  • Patients with no metachronous or synchronous multiple cancer
  • Patients without severe impairment of renal, hepatic and bone marrow functions
  • Patients who are judged to be capable of tolerating surgery
Show all 9Show fewer
  • Patients with preoperative performance status 0 to 2
  • Patients with no serious concurrent complications (such as bone marrow suppression, diarrhea and infection)
  • Patients who are judged to be capable of tolerating this treatment, and who have given written informed consent to participate in this study

Who cannot join

  • Patients with fresh hemorrhage from the gastrointestinal tract
  • Patients with retention of body fluid necessitating treatment
  • Patients with infection, intestinal palsy or intestinal occlusion
  • Patients who are pregnant or hope to become pregnant during the study period
  • Patients with diabetes treated by continuous use of insulin or showing poor glycemic control
  • Patients with a history of ischemic heart disease
Show all 10Show fewer
  • Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study
  • Patients receiving continuous administration of steroids
  • Patients who have experienced serious drug allergy in the past
  • Others, patients judged by the investigator or subinvestigator to be inappropriate as subject

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

Japan42 sites

  • Fukuchiyama City Hospital

    Fukuchiyama, Kyoto, 620-8505

  • Fukui Cardio Vascular Center

    Fukui-shi, Fukui, 910-0833

  • Fukui General Hospital

    Fukui-shi, Fukui, 910-8561

  • Fukui Saiseikai Hospital

    Fukui-shi, Fukui, 918-8503

  • Kyoto Ohashi General Hospital

    Fushimi, Kyoto, 612-8364

  • Gifu Municipal Hospital

    Gifu, Gifu, 500-8513

  • Gifu Prefectural General Medical Center

    Gifu, Gifu, 500-8717

  • Gifu University Hospital

    Gifu, Gifu, 501-1194

  • Kitade Hospital

    Gobou, Wakayama, 644-0011

  • Public Central Hospital of Matto Ishikawa

    Hakusan, Ishikawa-ken, 924-8588

  • University of Fukui Hospital

    Iijima, Fukui, 910-1193

  • Shimane University Hospital

    Izumo, Shimane, 693-8501

  • Houyu hospital

    Jōyō, Kyoto, 610-0121

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-0934

  • Ishikawa Prefectural Central Hospital

    Kanazawa, Ishikawa-ken, 920-8530

  • Kanazawa Redcross Hospital

    Kanazawa, Ishikawa-ken, 921-8162

  • Osaka City University Hospital

    Kembuchi, Osaka Abeno-ku, 545-8586

  • Shakaihoken Kobe Central Hospital

    Kobe, Hyōgo, 651-1145

  • Saiseikai Kyoto Hospital

    Kōtari, Kyoto, 617-0814

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

  • Nishijin Hospital

    Kyoto, Kyoto, 602-8800

  • Kyoto First Red Cross Hospital

    Kyoto, Kyoto, 605-0981

  • National Hospital Organization Maizuru Medical Center

    Maizuru, Kyoto, 625-8502

  • Matsushita Memorial Hospital

    Moriguchi, Osaka, 570-8540

  • Kanazawa Medical University Hospital

    Mukai-awagasaki, Ishikawa-ken, 920-0293

  • Sumitomo Hospital

    Nakanoshima, Osaka Kita-ku, 530-0005

  • Nantan General Hospital

    Nantan, Kyoto, 629-0197

  • Nara City Hospital

    Nara, Nara, 630-8305

  • Marutamachi Hospital

    Nishinokyokurumazaka-cho, Nakagyou-ku Kyoto, 604-8405

  • Osaka Railway hospital

    Osaka, Osaka, 545-0053

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192

  • Saiseikai Shigaken Hospital

    Rittō, Shiga, 520-3040

  • Saiseikai Takaoka Hospital

    Takaoka, Toyama, 933-8525

  • Kouseiren Takaoka Hoapital

    Takaoka, Toyama, 933-8555

  • Midorigaoka Hospital

    Takatsuki, Osaka, 569-1121

  • Toyama Prefectural Central Hospital

    Toyama, Toyama, 930-8550

  • National Hospital Organization Fukui Hospital

    Tsuruga, Fukui, 914-0195

  • Rokujizo Hospital

    Uji, Kyoto, 611-0001

  • Second Okamoto General Hospital

    Uji, Kyoto, 611-0025

  • Toyama Rosai Hospital

    Uozu, Toyama, 937-0042

  • Yatsuo General Hospital

    Yatsuomachi-higashikumisaka, Toyama, 939-2376

  • Kyoto Prefectural Yosanoumi Hospital

    Yotsutsuji, Kyoto, 629-2261

Other trials in Japan

About this study

Official title: Randomized Multicenter Controlled Phase III Study of Postoperative Adjuvant Therapy for Stage II/IIIA Gastric Cancer Using TS-1 Alone or TS-1+PSK Combined Therapy

A randomized controlled study is conducted on patients with resected gastric cancer assigned to postoperative adjuvant therapy of TS-1 alone or PSK combined with TS-1, with the objective to examine or validate the outcome, QOL and prognostic factors (host and tumor factors), and explore the factors enhancing the antitumor effect of TS-1.

Read the detailed description

The 5-year survival after gastric cancer surgery remains poor as the cancer advances to stages II, IIIA, IIIB and IV. Tegafur-gimeracil-oteracil potassium (TS-1) is used as the first line treatment for advanced and recurrent gastric cancer. But TS-1 is accompanied by an adverse drug reaction of bone marrow suppression that is not readily seen in conventional oral fluoropyrimidines. Among randomized controlled trials on postoperative adjuvant chemotherapy for gastric cancer, the beneficial results of survival rates using Krestin (PSK) in combination with chemotherapy have been reported. With the objective to enhance the antitumor effect of TS-1 and to improve the QOL of patients, we have planned to validate the clinical significance of combined PSK and TS-1 therapy as postoperative adjuvant therapy for gastric cancer, using in principle the TS-1 regimen of 2-week dosing 1-week off for 6 months followed by 2-week dosing 2-week off for 6 months.

Conditions
Gastric Cancer
Being tested
Tegafur-gimeracil-oteracil potassium (TS-1), Krestin (PSK)
Keywords
Gastric Cancer, TS-1, PSK, Disease-free survival, Overall survival
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Tegafur-gimeracil-oteracil potassium (TS-1)Drug

    Also called TS-1

    From 4-8 weeks after surgery to 27-31 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 21 day cycle. Number of Cycles: 8 From 28-32 weeks after surgery to 53-57 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 28 day cycle. Number of Cycles: 7

  • Krestin (PSK)Drug

    Also called PSK

    From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day

Study groups in NCT00216034
Study groupRoleWhat they receive
1Active comparatorTS-1 Group: The group treated with TS-1 mono-therapy
Receives: Drug: Tegafur-gimeracil-oteracil potassium (TS-1)
2ExperimentalTS-1+PSK Group: The group treated with combination therapy using TS-1 and PSK
Receives: Drug: Tegafur-gimeracil-oteracil potassium (TS-1); Drug: Krestin (PSK)

What is being measured

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

  1. Time of recurrence (calculation of 3-year disease-free survival and overall survival rates)

    Measured: Five years after surgery

Secondary outcomes (1)

  1. Relations of survival rate with compliance, postoperative complication, QOL, adverse events, recurrence status, and expression of immune or tumor markers

    Measured: Five years after surgery

Timeline

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

  1. First posted22 Sep 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

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
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00216034
Sponsor's protocol ID
HKIT-GC
Status last verified
Jun 2016
First submitted
18 Sep 2005
Last updated
7 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. Study Group of Immunochemotherapy with PSK for Gastric Cancer. Lancet. 1994 May 7;343(8906):1122-6. doi: 10.1016/s0140-6736(94)90233-x.

    PubMed 7910230

  • Ueda Y, Fujimura T, Kinami S, Hirono Y, Yamaguchi A, Naitoh H, Tani T, Kaji M, Yamagishi H, Miwa K; Hokuriku-Kinki Immunochemo-Therapy Study Group-Gastric Cancer (HKIT-GC). A randomized phase III trial of postoperative adjuvant therapy with S-1 alone versus S-1 plus PSK for stage II/IIIA gastric cancer: Hokuriku-Kinki Immunochemo-Therapy Study Group-Gastric Cancer (HKIT-GC). Jpn J Clin Oncol. 2006 Aug;36(8):519-22. doi: 10.1093/jjco/hyl048. Epub 2006 Jun 27.

    PubMed 16803844

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tegafur-gimeracil-oteracil potassium (TS-1) and Krestin (PSK) in people with Gastric Cancer, run by Hokuriku-Kinki Immunochemotherapy Study Group at 42 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 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 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?

Time of recurrence (calculation of 3-year disease-free survival and overall survival rates) (time frame: Five years after surgery). 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 NCT00216034, which also lists 2 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 7 Jun 2016.

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