Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK

Condition(s) targeted: Gastric Cancer

Intervention: Tegafur-gimeracil-oteracil potassium (TS-1) (Drug); Krestin (PSK) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hokuriku-Kinki Immunochemotherapy Study Group

Official(s) and/or principal investigator(s):
Koichi Miwa, MD, PhD, Study Chair, Affiliation: Hokuriku-Kinki Immunochemotherapy Study Group

Overall contact:
Takashi Fujimura, MD, PhD, Phone: +81-76-265-2362, Email: tphuji@surg2.m.kanazawa-u.ac.jp

A randomized controlled study is conducted on patients with resected gastric cancer assigned to postoperative adjuvant therapy of TS-1 alone or PSK combined with TS-1, with the objective to examine or validate the outcome, QOL and prognostic factors (host and tumor factors), and explore the factors enhancing the antitumor effect of TS-1.

Official title: Randomized Multicenter Controlled Phase III Study of Postoperative Adjuvant Therapy for Stage II/IIIA Gastric Cancer Using TS-1 Alone or TS-1+PSK Combined Therapy

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time of recurrence (calculation of 3-year disease-free survival and overall survival rates)

Secondary outcome: Relations of survival rate with compliance, postoperative complication, QOL, adverse events, recurrence status, and expression of immune or tumor markers

Detailed description: The 5-year survival after gastric cancer surgery remains poor as the cancer advances to stages II, IIIA, IIIB and IV. Tegafur-gimeracil-oteracil potassium (TS-1) is used as the first line treatment for advanced and recurrent gastric cancer. But TS-1 is accompanied by an adverse drug reaction of bone marrow suppression that is not readily seen in conventional oral fluoropyrimidines. Among randomized controlled trials on postoperative adjuvant chemotherapy for gastric cancer, the beneficial results of survival rates using Krestin (PSK) in combination with chemotherapy have been reported. With the objective to enhance the antitumor effect of TS-1 and to improve the QOL of patients, we have planned to validate the clinical significance of combined PSK and TS-1 therapy as postoperative adjuvant therapy for gastric cancer, using in principle the TS-1 regimen of 2-week dosing 1-week off for 6 months followed by 2-week dosing 2-week off for 6 months.

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with microscopic stage II or IIIA resectable gastric cancer

- Patients who have not received preoperative cancer therapy (radiotherapy, chemotherapy

or immunotherapy)

- Patients with serum immunosuppressive acidic protein (IAP) measured within 2 weeks

before surgery

- Patients with no metachronous or synchronous multiple cancer

- Patients without severe impairment of renal, hepatic and bone marrow functions

- Patients who are judged to be capable of tolerating surgery

- Patients with preoperative performance status 0 to 2

- Patients with no serious concurrent complications (such as bone marrow suppression,

diarrhea and infection)

- Patients who are judged to be capable of tolerating this treatment, and who have given

written informed consent to participate in this study

Exclusion Criteria:

- Patients with fresh hemorrhage from the gastrointestinal tract

- Patients with retention of body fluid necessitating treatment

- Patients with infection, intestinal palsy or intestinal occlusion

- Patients who are pregnant or hope to become pregnant during the study period

- Patients with diabetes treated by continuous use of insulin or showing poor glycemic

control

- Patients with a history of ischemic heart disease

- Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have

difficulties participating in the study

- Patients receiving continuous administration of steroids

- Patients who have experienced serious drug allergy in the past

- Others, patients judged by the investigator or subinvestigator to be inappropriate as

subject

Takashi Fujimura, MD, PhD, Phone: +81-76-265-2362, Email: tphuji@surg2.m.kanazawa-u.ac.jp

Fukui General Hospital, Fukui 910-8561, Japan; Recruiting
Toshimasa Izumi, Phone: +81-776-21-1300
Toshimasa Izumi, Principal Investigator

Fukui Cardio Vascular Center, Fukui 910-0833, Japan; Recruiting
Seiichi Taguchi, Phone: +81-776-54-5660
Seiichi Taguchi, Principal Investigator

Fukui Saiseikai Hospital, Fukui 918-8503, Japan; Recruiting
Yasuyuki Asada, Phone: +81-776-23-1111
Yasuyuki Asada, Principal Investigator

University Hospital, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan; Recruiting
Daisuke Ichikawa, Phone: +81-75-251-5527
Daisuke Ichikawa, Principal Investigator

Kyoto First Red Cross Hospital, Kyoto 605-0981, Japan; Recruiting
Yasuhiro Shioaki, Phone: +81-75-561-1121
Yasuhiro Shioaki, Principal Investigator

Nishijin Hospital, Kyoto 602-8800, Japan; Recruiting
Takuya Miyagaki, Phone: +81-75-461-8800
Takuya Miyagaki, Principal Investigator

Nara City Hospital, Nara 630-8305, Japan; Recruiting
Shozo Kitai, Phone: +81-742-24-1251
Shozo Kitai, Principal Investigator

Osaka Railwayhospital, Osaka 545-0053, Japan; Recruiting
Suguru Matsui, Phone: +81-6-6628-2221
Suguru Matsui, Principal Investigator

Toyama Prefectural Central Hospital, Toyama 930-8550, Japan; Recruiting
Masahide Kaji, Phone: +81-76-424-1531
Masahide Kaji, Principal Investigator

University of Fukui Hospital, Eiheiji, Fukui 910-1193, Japan; Recruiting
Yasuo Hirono, Phone: +81-776-61-3111
Yasuo Hirono, Principal Investigator

National Hospital Organization Fukui Hospital, Tsuruga, Fukui 914-0195, Japan; Recruiting
Makoto Ishida, Phone: +81-770-25-1600
Makoto Ishida, Principal Investigator

Shakaihoken Kobe Central Hospital, Kobe, Hyogo 651-1145, Japan; Recruiting
Atsushi Oguro, Phone: +81-78-594-2211
Atsushi Oguro, Principal Investigator

Kanazawa University Hospital, Kanazawa, Ishikawa 920-0934, Japan; Recruiting
Takashi Fujimura, MD, PhD, Phone: +81-76-265-2362, Email: tphuji@surg2.m.kanazawa-u.ac.jp
Takashi Fujimura, MD, PhD, Principal Investigator

Public Central Hospital of Matto Ishikawa, Hakusan, Ishikawa 924-8588, Japan; Recruiting
Masao Yagi, Phone: +81-76-275-2222
Masao Yagi, Principal Investigator

Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa 920-8530, Japan; Recruiting
Masaru Kurokawa, Phone: +81-76-237-8211
Masaru Kurokawa, Principal Investigator

Second Okamoto General Hospital, Uji, Kyoto 611-0025, Japan; Recruiting
Yoshihiro Shimizu, Phone: +81-774-44-4511
Yoshihiro Shimizu, Principal Investigator

Rokujizo Hospital, Uji, Kyoto 611-0001, Japan; Recruiting
Yasushi Koishi, Phone: +81-774-33-1717
Yasushi Koishi, Principal Investigator

Nantan General Hospital, Nantan, Kyoto 629-0197, Japan; Recruiting
Yuji Ueda, Phone: +81-771-42-2510
Yuji Ueda, Principal Investigator

National Hospital Organization Maizuru Medical Center, Maizuru, Kyoto 625-8502, Japan; Recruiting
Kouichi Shirono, Phone: +81-773-62-2680
Kouichi Shirono, Principal Investigator

Saiseikai Kyoto Hospital, Nagaokakyo, Kyoto 617-0814, Japan; Recruiting
Masaharu Yabe, Phone: +81-75-955-0111
Masaharu Yabe, Principal Investigator

Midorigaoka Hospital, Takatsuki, Osaka 569-1121, Japan; Recruiting
Takashi Nishiue, Phone: +81-72-681-5717
Takashi Nishiue, Principal Investigator

Matsushita Memorial Hospital, Moriguchi, Osaka 570-8540, Japan; Recruiting
Akinori Noguchi, Phone: +81-6-6992-1231
Akinori Noguchi, Principal Investigator

Shiga University of Medical Science Hospital, Otsu, Shiga 520-2192, Japan; Recruiting
Hiroshi Yamamoto, Phone: +81-77-548-2111
Hiroshi Yamamoto, Principal Investigator

Saiseikai Shigaken Hospital, Ritto, Shiga 520-3040, Japan; Recruiting
Mamoru Masuyama, Phone: +81-77-552-1221
Mamoru Masuyama, Principal Investigator

Toyama Rosai Hospital, Uozu, Toyama 937-0042, Japan; Recruiting
Nobuo Matsuki, Phone: +81-765-22-1280
Nobuo Matsuki, Principal Investigator

Saiseikai Takaoka Hospital, Takaoka, Toyama 933-8525, Japan; Recruiting
Nozomu Murakami, Phone: +81-766-21-0570
Nozomu Murakami, Principal Investigator

Kouseiren Takaoka Hoapital, Takaoka, Toyama 933-8555, Japan; Recruiting
Toshiyuki Okuda, Phone: +81-766-21-3930
Toshiyuki Okuda, Principal Investigator

Kitade Hospital, Gobou, Wakayama 644-0011, Japan; Recruiting
Motomi Wakasa, Phone: +81-738-22-2188
Motomi Wakasa, Principal Investigator

Related publications:

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.

Starting date: March 2005
Ending date: June 2014
Last updated: May 15, 2008