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

June 6, 2016 updated by: Takashi Fujimura, Hokuriku-Kinki Immunochemotherapy Study Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

255

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
      • Fukui, Japan, 910-0833
        • Fukui Cardio Vascular Center
      • Fukui, Japan, 910-8561
        • Fukui General Hospital
      • Fukui, Japan, 918-8503
        • Fukui Saiseikai Hospital
      • Gifu, Japan, 500-8717
        • Gifu Prefectural General Medical Center
      • Gifu, Japan, 500-8513
        • Gifu Municipal Hospital
      • Gifu, Japan, 501-1194
        • Gifu University Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital, Kyoto Prefectural University of Medicine
      • Kyoto, Japan, 605-0981
        • Kyoto First Red Cross Hospital
      • Kyoto, Japan, 602-8800
        • Nishijin Hospital
      • Nara, Japan, 630-8305
        • Nara City Hospital
      • Osaka, Japan, 545-0053
        • Osaka Railway hospital
      • Toyama, Japan, 930-8550
        • Toyama Prefectural Central Hospital
    • Fukui
      • Eiheiji, Fukui, Japan, 910-1193
        • University of Fukui Hospital
      • Tsuruga, Fukui, Japan, 914-0195
        • National Hospital Organization Fukui Hospital
    • Hyogo
      • Kobe, Hyogo, Japan, 651-1145
        • Shakaihoken Kobe Central Hospital
    • Ishikawa
      • Hakusan, Ishikawa, Japan, 924-8588
        • Public Central Hospital of Matto Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8530
        • Ishikawa Prefectural Central Hospital
      • Kanazawa, Ishikawa, Japan, 920-0934
        • Kanazawa University Hospital
      • Kanazawa, Ishikawa, Japan, 921-8162
        • Kanazawa Redcross Hospital
      • Uchinada, Ishikawa, Japan, 920-0293
        • Kanazawa Medical University Hospital
    • Kyoto
      • Fukuchiyama, Kyoto, Japan, 620-8505
        • Fukuchiyama City Hospital
      • Fushimi, Kyoto, Japan, 612-8364
        • Kyoto Ohashi General Hospital
      • Joyo, Kyoto, Japan, 610-0121
        • Houyu hospital
      • Maizuru, Kyoto, Japan, 625-8502
        • National Hospital Organization Maizuru Medical Center
      • Nagaokakyo, Kyoto, Japan, 617-0814
        • Saiseikai Kyoto Hospital
      • Nantan, Kyoto, Japan, 629-0197
        • Nantan General Hospital
      • Uji, Kyoto, Japan, 611-0001
        • Rokujizo Hospital
      • Uji, Kyoto, Japan, 611-0025
        • Second Okamoto General Hospital
      • Yosano, Kyoto, Japan, 629-2261
        • Kyoto Prefectural Yosanoumi Hospital
    • Nakagyou-ku Kyoto
      • Nishinokyokurumazaka-cho, Nakagyou-ku Kyoto, Japan, 604-8405
        • Marutamachi Hospital
    • Osaka
      • Moriguchi, Osaka, Japan, 570-8540
        • Matsushita Memorial Hospital
      • Takatsuki, Osaka, Japan, 569-1121
        • Midorigaoka Hospital
    • Osaka Abeno-ku
      • Asahi-machi, Osaka Abeno-ku, Japan, 545-8586
        • Osaka City University Hospital
    • Osaka Kita-ku
      • Nakanoshima, Osaka Kita-ku, Japan, 530-0005
        • Sumitomo Hospital
    • Shiga
      • Otsu, Shiga, Japan, 520-2192
        • Shiga University Of Medical Science Hospital
      • Ritto, Shiga, Japan, 520-3040
        • Saiseikai Shigaken Hospital
    • Shimane
      • Izumo, Shimane, Japan, 693-8501
        • Shimane University Hospital
    • Toyama
      • Takaoka, Toyama, Japan, 933-8525
        • Saiseikai Takaoka Hospital
      • Takaoka, Toyama, Japan, 933-8555
        • Kouseiren Takaoka Hoapital
      • Uozu, Toyama, Japan, 937-0042
        • Toyama Rosai Hospital
      • Yatsuo, Toyama, Japan, 939-2376
        • Yatsuo General Hospital
    • Wakayama
      • Gobou, Wakayama, Japan, 644-0011
        • Kitade 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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

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: 1
TS-1 Group: The group treated with TS-1 mono-therapy
Drug: Tegafur-gimeracil-oteracil potassium (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
Other Names:
  • TS-1
Experimental: 2
TS-1+PSK Group: The group treated with combination therapy using TS-1 and PSK
Drug: Tegafur-gimeracil-oteracil potassium (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
Other Names:
  • TS-1
Drug: Krestin (PSK)
From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day
Other Names:
  • PSK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time of recurrence (calculation of 3-year disease-free survival and overall survival rates)
Time Frame: Five years after surgery
Five years after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Relations of survival rate with compliance, postoperative complication, QOL, adverse events, recurrence status, and expression of immune or tumor markers
Time Frame: Five years after surgery
Five years after surgery

Collaborators and Investigators

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

Sponsor

Hokuriku-Kinki Immunochemotherapy Study Group

Investigators

  • Study Chair: Koichi Miwa, MD, PhD, Hokuriku-Kinki Immunochemotherapy Study Group

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, 2005

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 18, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

June 7, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKIT-GC

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.

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