study of ts-1 or ts-1 + psk for gastric cancer patients

Conditions: Gastric Cancer

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.

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 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

Keywords: gastric cancer ts-1 psk relapse-free survival