Status:
UNKNOWN
Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients
Lead Sponsor:
Tokyo Metropolitan Oncology Group
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
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+...
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 gastri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00687843
Start Date
June 1 2008
End Date
March 1 2016
Last Update
March 22 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Tokyo, Tokyo, Japan, 113-8677