Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK
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
1 other identifier
interventional
255
1 country
42
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 gastric-cancer
Started Mar 2005
Longer than P75 for phase_3 gastric-cancer
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 18, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedJune 7, 2016
June 1, 2016
10.9 years
September 18, 2005
June 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time of recurrence (calculation of 3-year disease-free survival and overall survival rates)
Five years after surgery
Secondary Outcomes (1)
Relations of survival rate with compliance, postoperative complication, QOL, adverse events, recurrence status, and expression of immune or tumor markers
Five years after surgery
Study Arms (2)
1
ACTIVE COMPARATORTS-1 Group: The group treated with TS-1 mono-therapy
2
EXPERIMENTALTS-1+PSK Group: The group treated with combination therapy using TS-1 and PSK
Interventions
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
From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Fukui Cardio Vascular Center
Fukui-shi, Fukui, 910-0833, Japan
Fukui General Hospital
Fukui-shi, Fukui, 910-8561, Japan
Fukui Saiseikai Hospital
Fukui-shi, Fukui, 918-8503, Japan
University of Fukui Hospital
Iijima, Fukui, 910-1193, Japan
National Hospital Organization Fukui Hospital
Tsuruga, Fukui, 914-0195, Japan
Gifu Municipal Hospital
Gifu, Gifu, 500-8513, Japan
Gifu Prefectural General Medical Center
Gifu, Gifu, 500-8717, Japan
Gifu University Hospital
Gifu, Gifu, 501-1194, Japan
Shakaihoken Kobe Central Hospital
Kobe, Hyōgo, 651-1145, Japan
Public Central Hospital of Matto Ishikawa
Hakusan, Ishikawa-ken, 924-8588, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-0934, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530, Japan
Kanazawa Redcross Hospital
Kanazawa, Ishikawa-ken, 921-8162, Japan
Kanazawa Medical University Hospital
Mukai-awagasaki, Ishikawa-ken, 920-0293, Japan
Fukuchiyama City Hospital
Fukuchiyama, Kyoto, 620-8505, Japan
Kyoto Ohashi General Hospital
Fushimi, Kyoto, 612-8364, Japan
Houyu hospital
Jōyō, Kyoto, 610-0121, Japan
Saiseikai Kyoto Hospital
Kōtari, Kyoto, 617-0814, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Nishijin Hospital
Kyoto, Kyoto, 602-8800, Japan
Kyoto First Red Cross Hospital
Kyoto, Kyoto, 605-0981, Japan
National Hospital Organization Maizuru Medical Center
Maizuru, Kyoto, 625-8502, Japan
Nantan General Hospital
Nantan, Kyoto, 629-0197, Japan
Rokujizo Hospital
Uji, Kyoto, 611-0001, Japan
Second Okamoto General Hospital
Uji, Kyoto, 611-0025, Japan
Kyoto Prefectural Yosanoumi Hospital
Yotsutsuji, Kyoto, 629-2261, Japan
Marutamachi Hospital
Nishinokyokurumazaka-cho, Nakagyou-ku Kyoto, 604-8405, Japan
Nara City Hospital
Nara, Nara, 630-8305, Japan
Matsushita Memorial Hospital
Moriguchi, Osaka, 570-8540, Japan
Osaka Railway hospital
Osaka, Osaka, 545-0053, Japan
Midorigaoka Hospital
Takatsuki, Osaka, 569-1121, Japan
Osaka City University Hospital
Kembuchi, Osaka Abeno-ku, 545-8586, Japan
Sumitomo Hospital
Nakanoshima, Osaka Kita-ku, 530-0005, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192, Japan
Saiseikai Shigaken Hospital
Rittō, Shiga, 520-3040, Japan
Shimane University Hospital
Izumo, Shimane, 693-8501, Japan
Saiseikai Takaoka Hospital
Takaoka, Toyama, 933-8525, Japan
Kouseiren Takaoka Hoapital
Takaoka, Toyama, 933-8555, Japan
Toyama Prefectural Central Hospital
Toyama, Toyama, 930-8550, Japan
Toyama Rosai Hospital
Uozu, Toyama, 937-0042, Japan
Yatsuo General Hospital
Yatsuomachi-higashikumisaka, Toyama, 939-2376, Japan
Kitade Hospital
Gobou, Wakayama, 644-0011, Japan
Related Publications (2)
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.
PMID: 7910230BACKGROUNDUeda Y, Fujimura T, Kinami S, Hirono Y, Yamaguchi A, Naitoh H, Tani T, Kaji M, Yamagishi H, Miwa K; Hokuriku-Kinki Immunochemo-Therapy Study Group-Gastric Cancer (HKIT-GC). A randomized phase III trial of postoperative adjuvant therapy with S-1 alone versus S-1 plus PSK for stage II/IIIA gastric cancer: Hokuriku-Kinki Immunochemo-Therapy Study Group-Gastric Cancer (HKIT-GC). Jpn J Clin Oncol. 2006 Aug;36(8):519-22. doi: 10.1093/jjco/hyl048. Epub 2006 Jun 27.
PMID: 16803844DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Koichi Miwa, MD, PhD
Hokuriku-Kinki Immunochemotherapy Study Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Gastroenterologic Surgery, Kanazawa University Hospital
Study Record Dates
First Submitted
September 18, 2005
First Posted
September 22, 2005
Study Start
March 1, 2005
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
June 7, 2016
Record last verified: 2016-06