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

Launched by TOKYO METROPOLITAN ONCOLOGY GROUP · May 30, 2008

Keywords

ClinConnect Summary

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 survi...

Gender

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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