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

May 28, 2008
March 20, 2012
June 2008
March 2016   (final data collection date for primary outcome measure)
Relapse-free survival [ Time Frame: Five years after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00687843 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • 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
  • Active Comparator: 1
    The TS-1 group
    Intervention: Drug: Tegafur-gimeracil-oteracil potassium (TS-1)
  • Experimental: 2
    The TS-1+PSK Group
    Interventions:
    • Drug: Tegafur-gimeracil-oteracil potassium (TS-1)
    • Drug: Krestin (PSK)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
480
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00687843
TMOG-GC01
Yes
Yoshiaki Iwasaki, M.D., Ph.D., Tokyo Metropolitan Oncology Group
Tokyo Metropolitan Oncology Group
Not Provided
Study Chair: Masatsugu Kitamura, MD
Tokyo Metropolitan Oncology Group
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP