Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients (TMOG-GC01)

Tokyo Metropolitan Oncology Group

Status and phase

Unknown

Phase 3

Conditions

Gastric Cancer

Treatments

Drug: Krestin (PSK)

Drug: Tegafur-gimeracil-oteracil potassium (TS-1)

Study type

Interventional

Funder types

Other

Identifiers

NCT00687843

TMOG-GC01

Details and patient eligibility

About

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.

Full 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.

Enrollment

480 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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