Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients
This trial is active, not recruiting.
|Treatments||tegafur-gimeracil-oteracil potassium (ts-1), krestin (psk)|
|Sponsor||Tokyo Metropolitan Oncology Group|
|Start date||June 2008|
|End date||March 2016|
|Trial size||480 participants|
|Trial identifier||NCT00687843, TMOG-GC01|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: Five years after surgery
Overall survival, quality of life, drug compliance, adverse events, serial changes of tumor markers
time frame: Five years after surgery
Male or female participants from 20 years up to 80 years old.
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
|Official title||Phase III Randomized Controlled Study of Postoperative Adjuvant Therapy Using TS-1 or TS-1+PSK for Stage II or III Gastric Cancer Patients|
|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.|
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