Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients (TMOG-GC01)

March 20, 2012 updated by: Yoshiaki Iwasaki, M.D., Ph.D., Tokyo Metropolitan Oncology Group

Phase III Randomized Controlled Study of Postoperative Adjuvant Therapy Using TS-1 or TS-1+PSK for Stage II or III Gastric Cancer Patients

Since it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer, in this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

TS-1 is an oral anticancer drug approved in Japan consisting of tegafur (a pro-drug of fluorouracil, 5-FU), gimeracil and oteracil potassium. The response rate of TS-1 in the untreated advanced gastric cancer patients was 44.6% in the late phase II study. In 2007, efficacy of the adjuvant therapy using TS-1 in the resected gastric cancer patients was demonstrated by ACTS-GC study group conducted in Japan. PSK is an oral anticancer drug approved in Japan consisting of protein-bound polysaccharide extracted from mycelium of Trametes (Coriolus) versicolor, a kind of mushroom. Even though survival benefit by PSK in combination with adjuvant chemotherapy using 5-FU or tegafur in the postoperative gastric cancer patients was already demonstrated, it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer. In this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.

Study Type

Interventional

Enrollment (Anticipated)

480

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
      • Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Cancer and Infectious disease Center Komagome 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:

  • Patient who is pathologically confirmed as gastric cancer
  • Patient who has received surgery with D2 or more lymph node dissection and whose final curability of surgical resection is grade A or B
  • Patient whose final stage is II (except for T1), IIIA, or IIIB
  • Patient without liver, peritoneal and distant metastasis, and who is negative in peritoneal cytological diagnosis
  • Patient whose age at the registration is ranging between 20 and 80 years old
  • Patient who has not received any preoperative therapy including radiotherapy, chemotherapy and immunotherapy
  • Patient who has received surgery for gastric cancer within six weeks before the registration, and is judged to be capable of oral administration

  • Patient who has no serious concurrent complications, and satisfies the following criteria

    • White blood cell count: > LLN or > 4,000 /mm3
    • Platelet count: > 100,000 /mm3
    • Serum total bilirubin: < 1.5 mg/dL
    • Serum AST (GOT), ALT (GPT): < 2.5 * ULN
    • Serum creatinine: < ULN
  • Patient who has received an explanation of this study by assent documents, and has given written informed consent to participate in this study

Exclusion Criteria:

  • Patient with metachronous or synchronous multicancer
  • Patient who contraindicates to TS-1
  • Patient who requires continuous use of flucytosine, phenytoin or warfarin potassium
  • Patient who has experienced serious drug allergy over grade 3 in the past
  • Patient with serious complications including paralysis of intestine, ileus, interstitial pneumonitis, fibroid lung, uncontrollable diabetes mellitus, heart insufficiency, renal insufficiency or hepatic insufficiency
  • Patient with diarrhea (watery stool)
  • Patient who is pregnant or in lactation, or wish to become pregnant during this study
  • Male patient who intends to make someone pregnant during this study
  • Patient with HIV positive
  • Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge

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
The TS-1 group
Drug: Tegafur-gimeracil-oteracil potassium (TS-1)
80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8
Other Names:
  • TS-1
Experimental: 2
The TS-1+PSK Group
Drug: Tegafur-gimeracil-oteracil potassium (TS-1)
80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8
Other Names:
  • TS-1
Drug: Krestin (PSK)
3 g, PO from day 1 to day 336
Other Names:
  • PSK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse-free survival
Time Frame: Five years after surgery
Five years after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival, quality of life, drug compliance, adverse events, serial changes of 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

Tokyo Metropolitan Oncology Group

Investigators

  • Study Chair: Masatsugu Kitamura, MD

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

June 1, 2008

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (Estimate)

June 2, 2008

Study Record Updates

Last Update Posted (Estimate)

March 22, 2012

Last Update Submitted That Met QC Criteria

March 20, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMOG-GC01

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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