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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takashi Fujimura, Hokuriku-Kinki Immunochemotherapy Study Group
ClinicalTrials.gov Identifier:
NCT00216034
First received: September 18, 2005
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Other Name: TS-1
Experimental: 2
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
Other Name: TS-1
Drug: Krestin (PSK)
From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day
Other Name: PSK

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

Locations
Japan
University of Fukui Hospital
Eiheiji, Fukui, Japan, 910-1193
National Hospital Organization Fukui Hospital
Tsuruga, Fukui, Japan, 914-0195
Shakaihoken Kobe Central Hospital
Kobe, Hyogo, Japan, 651-1145
Public Central Hospital of Matto Ishikawa
Hakusan, Ishikawa, Japan, 924-8588
Kanazawa Redcross Hospital
Kanazawa, Ishikawa, Japan, 921-8162
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa, Japan, 920-8530
Kanazawa University Hospital
Kanazawa, Ishikawa, Japan, 920-0934
Kanazawa Medical University Hospital
Uchinada, Ishikawa, Japan, 920-0293
Fukuchiyama City Hospital
Fukuchiyama, Kyoto, Japan, 620-8505
Kyoto Ohashi General Hospital
Fushimi, Kyoto, Japan, 612-8364
Houyu hospital
Joyo, Kyoto, Japan, 610-0121
National Hospital Organization Maizuru Medical Center
Maizuru, Kyoto, Japan, 625-8502
Saiseikai Kyoto Hospital
Nagaokakyo, Kyoto, Japan, 617-0814
Nantan General Hospital
Nantan, Kyoto, Japan, 629-0197
Rokujizo Hospital
Uji, Kyoto, Japan, 611-0001
Second Okamoto General Hospital
Uji, Kyoto, Japan, 611-0025
Kyoto Prefectural Yosanoumi Hospital
Yosano, Kyoto, Japan, 629-2261
Marutamachi Hospital
Nishinokyokurumazaka-cho, Nakagyou-ku Kyoto, Japan, 604-8405
Osaka City University Hospital
Asahi-machi, Osaka Abeno-ku, Japan, 545-8586
Sumitomo Hospital
Nakanoshima, Osaka Kita-ku, Japan, 530-0005
Matsushita Memorial Hospital
Moriguchi, Osaka, Japan, 570-8540
Midorigaoka Hospital
Takatsuki, Osaka, Japan, 569-1121
Shiga University of Medical Science Hospital
Otsu, Shiga, Japan, 520-2192
Saiseikai Shigaken Hospital
Ritto, Shiga, Japan, 520-3040
Shimane University Hospital
Izumo, Shimane, Japan, 693-8501
Kouseiren Takaoka Hoapital
Takaoka, Toyama, Japan, 933-8555
Saiseikai Takaoka Hospital
Takaoka, Toyama, Japan, 933-8525
Toyama Rosai Hospital
Uozu, Toyama, Japan, 937-0042
Yatsuo General Hospital
Yatsuo, Toyama, Japan, 939-2376
Kitade Hospital
Gobou, Wakayama, Japan, 644-0011
Fukui General Hospital
Fukui, Japan, 910-8561
Fukui Cardio Vascular Center
Fukui, Japan, 910-0833
Fukui Saiseikai Hospital
Fukui, Japan, 918-8503
Gifu Prefectural General Medical Center
Gifu, Japan, 500-8717
Gifu Municipal Hospital
Gifu, Japan, 500-8513
Gifu University Hospital
Gifu, Japan, 501-1194
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Kyoto First Red Cross Hospital
Kyoto, Japan, 605-0981
Nishijin Hospital
Kyoto, Japan, 602-8800
Nara City Hospital
Nara, Japan, 630-8305
Osaka Railway hospital
Osaka, Japan, 545-0053
Toyama Prefectural Central Hospital
Toyama, Japan, 930-8550
Sponsors and Collaborators
Hokuriku-Kinki Immunochemotherapy Study Group
Investigators
Study Chair: Koichi Miwa, MD, PhD Hokuriku-Kinki Immunochemotherapy Study Group
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Takashi Fujimura, Assistant Professor of Gastroenterologic Surgery, Kanazawa University Hospital, Hokuriku-Kinki Immunochemotherapy Study Group
ClinicalTrials.gov Identifier: NCT00216034     History of Changes
Other Study ID Numbers: HKIT-GC
Study First Received: September 18, 2005
Last Updated: March 20, 2012
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

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Tegafur
S 1 (combination)
Krestin
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013