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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yoshiaki Iwasaki, M.D., Ph.D., Tokyo Metropolitan Oncology Group
ClinicalTrials.gov Identifier:
NCT00687843
First received: May 28, 2008
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
 Drug: Tegafur-gimeracil-oteracil potassium (TS-1)
Drug: Krestin (PSK)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Controlled Study of Postoperative Adjuvant Therapy Using TS-1 or TS-1+PSK for Stage II or III Gastric Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tokyo Metropolitan Oncology Group:

Primary Outcome Measures:
  • Relapse-free survival [ Time Frame: Five years after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival, quality of life, drug compliance, adverse events, serial changes of tumor markers [ Time Frame: Five years after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 480
Study Start Date: June 2008
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: TS-1
Drug: Krestin (PSK)
3 g, PO from day 1 to day 336
Other Name: PSK

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687843

Locations
Japan
Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Tokyo, Japan, 113-8677
Sponsors and Collaborators
Tokyo Metropolitan Oncology Group
Investigators
Study Chair: Masatsugu Kitamura, MD
  More Information

Publications:

Responsible Party: Yoshiaki Iwasaki, M.D., Ph.D., Department of Surgery, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital., Tokyo Metropolitan Oncology Group
ClinicalTrials.gov Identifier: NCT00687843     History of Changes
Other Study ID Numbers: TMOG-GC01
Study First Received: May 28, 2008
Last Updated: March 20, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Tokyo Metropolitan Oncology Group:
Gastric Cancer
TS-1
PSK
Relapse-free survival

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Tegafur
S 1 (combination)
Krestin
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013