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Sponsored by: |
Hokuriku-Kinki Immunochemotherapy Study Group |
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Information provided by: | Hokuriku-Kinki Immunochemotherapy Study Group |
ClinicalTrials.gov Identifier: | NCT00216034 |
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.
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer |
Drug: Tegafur-gimeracil-oteracil potassium (TS-1) Drug: Krestin (PSK) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 280 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | June 2014 |
Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
TS-1 Group: The group treated with TS-1 mono-therapy
|
Drug: Tegafur-gimeracil-oteracil potassium (TS-1)
From 4-8 weeks after surgery to 27-31 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 21 day cycle. Number of Cycles: 8 From 28-32 weeks after surgery to 53-57 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 28 day cycle. Number of Cycles: 7
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2: Experimental
TS-1+PSK Group: The group treated with combination therapy using TS-1 and PSK
|
Drug: Tegafur-gimeracil-oteracil potassium (TS-1)
From 4-8 weeks after surgery to 27-31 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 21 day cycle. Number of Cycles: 8 From 28-32 weeks after surgery to 53-57 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 28 day cycle. Number of Cycles: 7
Drug: Krestin (PSK)
From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day
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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.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Takashi Fujimura, MD, PhD | +81-76-265-2362 | tphuji@surg2.m.kanazawa-u.ac.jp |
Japan | |
Fukui General Hospital | Recruiting |
Fukui, Japan, 910-8561 | |
Contact: Toshimasa Izumi +81-776-21-1300 | |
Principal Investigator: Toshimasa Izumi | |
Fukui Cardio Vascular Center | Recruiting |
Fukui, Japan, 910-0833 | |
Contact: Seiichi Taguchi +81-776-54-5660 | |
Principal Investigator: Seiichi Taguchi | |
Fukui Saiseikai Hospital | Recruiting |
Fukui, Japan, 918-8503 | |
Contact: Yasuyuki Asada +81-776-23-1111 | |
Principal Investigator: Yasuyuki Asada | |
Nara City Hospital | Recruiting |
Nara, Japan, 630-8305 | |
Contact: Shozo Kitai +81-742-24-1251 | |
Principal Investigator: Shozo Kitai | |
Kyoto First Red Cross Hospital | Recruiting |
Kyoto, Japan, 605-0981 | |
Contact: Yasuhiro Shioaki +81-75-561-1121 | |
Principal Investigator: Yasuhiro Shioaki | |
Nishijin Hospital | Recruiting |
Kyoto, Japan, 602-8800 | |
Contact: Takuya Miyagaki +81-75-461-8800 | |
Principal Investigator: Takuya Miyagaki | |
University Hospital, Kyoto Prefectural University of Medicine | Recruiting |
Kyoto, Japan, 602-8566 | |
Contact: Daisuke Ichikawa +81-75-251-5527 | |
Principal Investigator: Daisuke Ichikawa | |
Osaka Railwayhospital | Recruiting |
Osaka, Japan, 545-0053 | |
Contact: Suguru Matsui +81-6-6628-2221 | |
Principal Investigator: Suguru Matsui | |
Toyama Prefectural Central Hospital | Recruiting |
Toyama, Japan, 930-8550 | |
Contact: Masahide Kaji +81-76-424-1531 | |
Principal Investigator: Masahide Kaji | |
Japan, Fukui | |
University of Fukui Hospital | Recruiting |
Eiheiji, Fukui, Japan, 910-1193 | |
Contact: Yasuo Hirono +81-776-61-3111 | |
Principal Investigator: Yasuo Hirono | |
National Hospital Organization Fukui Hospital | Recruiting |
Tsuruga, Fukui, Japan, 914-0195 | |
Contact: Makoto Ishida +81-770-25-1600 | |
Principal Investigator: Makoto Ishida | |
Japan, Hyogo | |
Shakaihoken Kobe Central Hospital | Recruiting |
Kobe, Hyogo, Japan, 651-1145 | |
Contact: Atsushi Oguro +81-78-594-2211 | |
Principal Investigator: Atsushi Oguro | |
Japan, Ishikawa | |
Kanazawa University Hospital | Recruiting |
Kanazawa, Ishikawa, Japan, 920-0934 | |
Contact: Takashi Fujimura, MD, PhD +81-76-265-2362 tphuji@surg2.m.kanazawa-u.ac.jp | |
Principal Investigator: Takashi Fujimura, MD, PhD | |
Public Central Hospital of Matto Ishikawa | Recruiting |
Hakusan, Ishikawa, Japan, 924-8588 | |
Contact: Masao Yagi +81-76-275-2222 | |
Principal Investigator: Masao Yagi | |
Ishikawa Prefectural Central Hospital | Recruiting |
Kanazawa, Ishikawa, Japan, 920-8530 | |
Contact: Masaru Kurokawa +81-76-237-8211 | |
Principal Investigator: Masaru Kurokawa | |
Japan, Kyoto | |
Second Okamoto General Hospital | Recruiting |
Uji, Kyoto, Japan, 611-0025 | |
Contact: Yoshihiro Shimizu +81-774-44-4511 | |
Principal Investigator: Yoshihiro Shimizu | |
Rokujizo Hospital | Recruiting |
Uji, Kyoto, Japan, 611-0001 | |
Contact: Yasushi Koishi +81-774-33-1717 | |
Principal Investigator: Yasushi Koishi | |
Nantan General Hospital | Recruiting |
Nantan, Kyoto, Japan, 629-0197 | |
Contact: Yuji Ueda +81-771-42-2510 | |
Principal Investigator: Yuji Ueda | |
National Hospital Organization Maizuru Medical Center | Recruiting |
Maizuru, Kyoto, Japan, 625-8502 | |
Contact: Kouichi Shirono +81-773-62-2680 | |
Principal Investigator: Kouichi Shirono | |
Saiseikai Kyoto Hospital | Recruiting |
Nagaokakyo, Kyoto, Japan, 617-0814 | |
Contact: Masaharu Yabe +81-75-955-0111 | |
Principal Investigator: Masaharu Yabe | |
Japan, Osaka | |
Midorigaoka Hospital | Recruiting |
Takatsuki, Osaka, Japan, 569-1121 | |
Contact: Takashi Nishiue +81-72-681-5717 | |
Principal Investigator: Takashi Nishiue | |
Matsushita Memorial Hospital | Recruiting |
Moriguchi, Osaka, Japan, 570-8540 | |
Contact: Akinori Noguchi +81-6-6992-1231 | |
Principal Investigator: Akinori Noguchi | |
Japan, Shiga | |
Shiga University of Medical Science Hospital | Recruiting |
Otsu, Shiga, Japan, 520-2192 | |
Contact: Hiroshi Yamamoto +81-77-548-2111 | |
Principal Investigator: Hiroshi Yamamoto | |
Saiseikai Shigaken Hospital | Recruiting |
Ritto, Shiga, Japan, 520-3040 | |
Contact: Mamoru Masuyama +81-77-552-1221 | |
Principal Investigator: Mamoru Masuyama | |
Japan, Toyama | |
Toyama Rosai Hospital | Recruiting |
Uozu, Toyama, Japan, 937-0042 | |
Contact: Nobuo Matsuki +81-765-22-1280 | |
Principal Investigator: Nobuo Matsuki | |
Saiseikai Takaoka Hospital | Recruiting |
Takaoka, Toyama, Japan, 933-8525 | |
Contact: Nozomu Murakami +81-766-21-0570 | |
Principal Investigator: Nozomu Murakami | |
Kouseiren Takaoka Hoapital | Recruiting |
Takaoka, Toyama, Japan, 933-8555 | |
Contact: Toshiyuki Okuda +81-766-21-3930 | |
Principal Investigator: Toshiyuki Okuda | |
Japan, Wakayama | |
Kitade Hospital | Recruiting |
Gobou, Wakayama, Japan, 644-0011 | |
Contact: Motomi Wakasa +81-738-22-2188 | |
Principal Investigator: Motomi Wakasa |
Study Chair: | Koichi Miwa, MD, PhD | Hokuriku-Kinki Immunochemotherapy Study Group |
Responsible Party: | Kanazawa University Hospital ( Takashi Fujimura, Assistant Professor of Gastroenterologic Surgery ) |
Study ID Numbers: | HKIT-GC |
Study First Received: | September 18, 2005 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00216034 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Gastric Cancer TS-1 PSK Disease-free survival Overall survival |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Tegafur Gastrointestinal Diseases |
Stomach Neoplasms Interferons Gastrointestinal Neoplasms Stomach cancer PS-K |
Anti-Infective Agents Interferon Inducers Radiation-Protective Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic |
Antibiotics, Antineoplastic Protective Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses |