Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients

Summary: 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.

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: 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

Relevance to patient case: not relevant