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

NCT ID: NCT00687843

Last Updated: 2012-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2016-03-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

The TS-1 group

Group Type: ACTIVE_COMPARATOR

Tegafur-gimeracil-oteracil potassium (TS-1)

Intervention Type: DRUG

80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8

2

The TS-1+PSK Group

Group Type: EXPERIMENTAL

Tegafur-gimeracil-oteracil potassium (TS-1)

Intervention Type: DRUG

80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8

Krestin (PSK)

Intervention Type: DRUG

3 g, PO from day 1 to day 336

Interventions

Tegafur-gimeracil-oteracil potassium (TS-1)

80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8

Intervention Type: DRUG

Krestin (PSK)

3 g, PO from day 1 to day 336

Intervention Type: DRUG

Other Intervention Names

TS-1; PSK

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokyo Metropolitan Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Yoshiaki Iwasaki, M.D., Ph.D.

Department of Surgery, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Masatsugu Kitamura, MD

Role: STUDY_CHAIR

Locations

Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital

Tokyo, Tokyo, Japan

Countries

Japan

References

Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.

Reference Type: BACKGROUND

PMID: 17978289 (View on PubMed)

Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. Study Group of Immunochemotherapy with PSK for Gastric Cancer. Lancet. 1994 May 7;343(8906):1122-6. doi: 10.1016/s0140-6736(94)90233-x.

Reference Type: BACKGROUND

PMID: 7910230 (View on PubMed)

Other Identifiers

TMOG-GC01

Identifier Type: -

Identifier Source: org_study_id