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


Phase 3
20 Years
80 Years
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

Phase III Randomized Controlled Study of Postoperative Adjuvant Therapy Using TS-1 or TS-1+PSK for 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relapse-free survival

Outcome Time Frame:

Five years after surgery

Safety Issue:

No

Principal Investigator

Masatsugu Kitamura, MD

Investigator Role:

Study Chair

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

TMOG-GC01

NCT ID:

NCT00687843

Start Date:

June 2008

Completion Date:

March 2016

Related Keywords:

  • Gastric Cancer
  • Gastric Cancer
  • TS-1
  • PSK
  • Relapse-free survival
  • Stomach Neoplasms

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