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Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK
This study is currently recruiting participants.
Verified by Hokuriku-Kinki Immunochemotherapy Study Group, May 2008
Sponsored by: Hokuriku-Kinki Immunochemotherapy Study Group
Information provided by: Hokuriku-Kinki Immunochemotherapy Study Group
ClinicalTrials.gov Identifier: NCT00216034
  Purpose

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

MedlinePlus related topics: Cancer Stomach Cancer
Drug Information available for: Tegafur Krestin Potassium chloride Oxonic acid 5-Chloro-2,4-dihydroxypyridine S 1 (Combination)
U.S. FDA Resources
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

Further study details as provided by Hokuriku-Kinki Immunochemotherapy Study Group:

Primary Outcome Measures:
  • Time of recurrence (calculation of 3-year disease-free survival and overall survival rates) [ Time Frame: Five years after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relations of survival rate with compliance, postoperative complication, QOL, adverse events, recurrence status, and expression of immune or tumor markers [ Time Frame: Five years after surgery ] [ Designated as safety issue: Yes ]

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
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00216034

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

Locations
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            
Sponsors and Collaborators
Hokuriku-Kinki Immunochemotherapy Study Group
Investigators
Study Chair: Koichi Miwa, MD, PhD Hokuriku-Kinki Immunochemotherapy Study Group
  More Information

Publications:
Publications indexed to this study:
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

Keywords provided by Hokuriku-Kinki Immunochemotherapy Study Group:
Gastric Cancer
TS-1
PSK
Disease-free survival
Overall survival

Study placed in the following topic categories:
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Tegafur
Gastrointestinal Diseases
Stomach Neoplasms
Interferons
Gastrointestinal Neoplasms
Stomach cancer
PS-K

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009