Gastric Cancer
Conditions
Keywords
Gastric Cancer, TS-1, PSK, Relapse-free survival
Brief 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.
Interventions
80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8
DRUGKrestin (PSK)
3 g, PO from day 1 to day 336
Sponsors
Tokyo Metropolitan Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival | Five years after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, quality of life, drug compliance, adverse events, serial changes of tumor markers | Five years after surgery |
Countries
Japan
Outcome results
None listed