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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Tegafur-gimeracil-oteracil potassium (TS-1)
Krestin (PSK)
Sponsored by
Hokuriku-Kinki Immunochemotherapy Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, TS-1, PSK, Disease-free survival, Overall survival

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Fukui Hospital
  • National Hospital Organization Fukui Hospital
  • Shakaihoken Kobe Central Hospital
  • Public Central Hospital of Matto Ishikawa
  • Kanazawa University Hospital
  • Ishikawa Prefectural Central Hospital
  • Kanazawa Redcross Hospital
  • Kanazawa Medical University Hospital
  • Fukuchiyama City Hospital
  • Kyoto Ohashi General Hospital
  • Houyu hospital
  • National Hospital Organization Maizuru Medical Center
  • Saiseikai Kyoto Hospital
  • Nantan General Hospital
  • Rokujizo Hospital
  • Second Okamoto General Hospital
  • Kyoto Prefectural Yosanoumi Hospital
  • Marutamachi Hospital
  • Osaka City University Hospital
  • Sumitomo Hospital
  • Matsushita Memorial Hospital
  • Midorigaoka Hospital
  • Shiga University of Medical Science Hospital
  • Saiseikai Shigaken Hospital
  • Shimane University Hospital
  • Saiseikai Takaoka Hospital
  • Kouseiren Takaoka Hoapital
  • Toyama Rosai Hospital
  • Yatsuo General Hospital
  • Kitade Hospital
  • Fukui Cardio Vascular Center
  • Fukui General Hospital
  • Fukui Saiseikai Hospital
  • Gifu Municipal Hospital
  • Gifu Prefectural General Medical Center
  • Gifu University Hospital
  • University Hospital, Kyoto Prefectural University of Medicine
  • Nishijin Hospital
  • Kyoto First Red Cross Hospital
  • Nara City Hospital
  • Osaka Railway hospital
  • Toyama Prefectural Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

TS-1 Group: The group treated with TS-1 mono-therapy

TS-1+PSK Group: The group treated with combination therapy using TS-1 and PSK

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 18, 2005
Last Updated
June 6, 2016
Sponsor
Hokuriku-Kinki Immunochemotherapy Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00216034
Brief Title
Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK
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 Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hokuriku-Kinki Immunochemotherapy Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric Cancer, TS-1, PSK, Disease-free survival, Overall survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
TS-1 Group: The group treated with TS-1 mono-therapy
Arm Title
2
Arm Type
Experimental
Arm Description
TS-1+PSK Group: The group treated with combination therapy using TS-1 and PSK
Intervention Type
Drug
Intervention Name(s)
Tegafur-gimeracil-oteracil potassium (TS-1)
Other Intervention Name(s)
TS-1
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Krestin (PSK)
Other Intervention Name(s)
PSK
Intervention Description
From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day
Primary Outcome Measure Information:
Title
Time of recurrence (calculation of 3-year disease-free survival and overall survival rates)
Time Frame
Five years after surgery
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koichi Miwa, MD, PhD
Organizational Affiliation
Hokuriku-Kinki Immunochemotherapy Study Group
Official's Role
Study Chair
Facility Information:
Facility Name
University of Fukui Hospital
City
Eiheiji
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
National Hospital Organization Fukui Hospital
City
Tsuruga
State/Province
Fukui
ZIP/Postal Code
914-0195
Country
Japan
Facility Name
Shakaihoken Kobe Central Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
651-1145
Country
Japan
Facility Name
Public Central Hospital of Matto Ishikawa
City
Hakusan
State/Province
Ishikawa
ZIP/Postal Code
924-8588
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-0934
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Kanazawa Redcross Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
921-8162
Country
Japan
Facility Name
Kanazawa Medical University Hospital
City
Uchinada
State/Province
Ishikawa
ZIP/Postal Code
920-0293
Country
Japan
Facility Name
Fukuchiyama City Hospital
City
Fukuchiyama
State/Province
Kyoto
ZIP/Postal Code
620-8505
Country
Japan
Facility Name
Kyoto Ohashi General Hospital
City
Fushimi
State/Province
Kyoto
ZIP/Postal Code
612-8364
Country
Japan
Facility Name
Houyu hospital
City
Joyo
State/Province
Kyoto
ZIP/Postal Code
610-0121
Country
Japan
Facility Name
National Hospital Organization Maizuru Medical Center
City
Maizuru
State/Province
Kyoto
ZIP/Postal Code
625-8502
Country
Japan
Facility Name
Saiseikai Kyoto Hospital
City
Nagaokakyo
State/Province
Kyoto
ZIP/Postal Code
617-0814
Country
Japan
Facility Name
Nantan General Hospital
City
Nantan
State/Province
Kyoto
ZIP/Postal Code
629-0197
Country
Japan
Facility Name
Rokujizo Hospital
City
Uji
State/Province
Kyoto
ZIP/Postal Code
611-0001
Country
Japan
Facility Name
Second Okamoto General Hospital
City
Uji
State/Province
Kyoto
ZIP/Postal Code
611-0025
Country
Japan
Facility Name
Kyoto Prefectural Yosanoumi Hospital
City
Yosano
State/Province
Kyoto
ZIP/Postal Code
629-2261
Country
Japan
Facility Name
Marutamachi Hospital
City
Nishinokyokurumazaka-cho
State/Province
Nakagyou-ku Kyoto
ZIP/Postal Code
604-8405
Country
Japan
Facility Name
Osaka City University Hospital
City
Asahi-machi
State/Province
Osaka Abeno-ku
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Sumitomo Hospital
City
Nakanoshima
State/Province
Osaka Kita-ku
ZIP/Postal Code
530-0005
Country
Japan
Facility Name
Matsushita Memorial Hospital
City
Moriguchi
State/Province
Osaka
ZIP/Postal Code
570-8540
Country
Japan
Facility Name
Midorigaoka Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1121
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Saiseikai Shigaken Hospital
City
Ritto
State/Province
Shiga
ZIP/Postal Code
520-3040
Country
Japan
Facility Name
Shimane University Hospital
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Saiseikai Takaoka Hospital
City
Takaoka
State/Province
Toyama
ZIP/Postal Code
933-8525
Country
Japan
Facility Name
Kouseiren Takaoka Hoapital
City
Takaoka
State/Province
Toyama
ZIP/Postal Code
933-8555
Country
Japan
Facility Name
Toyama Rosai Hospital
City
Uozu
State/Province
Toyama
ZIP/Postal Code
937-0042
Country
Japan
Facility Name
Yatsuo General Hospital
City
Yatsuo
State/Province
Toyama
ZIP/Postal Code
939-2376
Country
Japan
Facility Name
Kitade Hospital
City
Gobou
State/Province
Wakayama
ZIP/Postal Code
644-0011
Country
Japan
Facility Name
Fukui Cardio Vascular Center
City
Fukui
ZIP/Postal Code
910-0833
Country
Japan
Facility Name
Fukui General Hospital
City
Fukui
ZIP/Postal Code
910-8561
Country
Japan
Facility Name
Fukui Saiseikai Hospital
City
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
Gifu Municipal Hospital
City
Gifu
ZIP/Postal Code
500-8513
Country
Japan
Facility Name
Gifu Prefectural General Medical Center
City
Gifu
ZIP/Postal Code
500-8717
Country
Japan
Facility Name
Gifu University Hospital
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Nishijin Hospital
City
Kyoto
ZIP/Postal Code
602-8800
Country
Japan
Facility Name
Kyoto First Red Cross Hospital
City
Kyoto
ZIP/Postal Code
605-0981
Country
Japan
Facility Name
Nara City Hospital
City
Nara
ZIP/Postal Code
630-8305
Country
Japan
Facility Name
Osaka Railway hospital
City
Osaka
ZIP/Postal Code
545-0053
Country
Japan
Facility Name
Toyama Prefectural Central Hospital
City
Toyama
ZIP/Postal Code
930-8550
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
7910230
Citation
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.
Results Reference
background
PubMed Identifier
16803844
Citation
Ueda 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.
Results Reference
derived

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

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