Clinical trial NCT00216034: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Gastric Cancer
TS-1
PSK
Disease-free survival
Overall survival
Lead sponsor: Hokuriku-Kinki Immunochemotherapy Study Group
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 255
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time of recurrence (calculation of 3-year disease-free survival and overall survival rates)
timeFrame: Five years after surgery
Secondary outcomes:
measure: Relations of survival rate with compliance, postoperative complication, QOL, adverse events, recurrence status, and expression of immune or tumor markers
timeFrame: Five years after surgery
Other outcomes:
Locations:
city: Eiheiji
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Tsuruga
country: Japan
facility: National Hospital Organization Fukui Hospital
state: Fukui
city: Kobe
country: Japan
facility: Shakaihoken Kobe Central Hospital
state: Hyogo
city: Hakusan
country: Japan
facility: Public Central Hospital of Matto Ishikawa
state: Ishikawa
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Kanazawa
country: Japan
facility: Kanazawa Redcross Hospital
state: Ishikawa
city: Uchinada
country: Japan
facility: Kanazawa Medical University Hospital
state: Ishikawa
city: Fukuchiyama
country: Japan
facility: Fukuchiyama City Hospital
state: Kyoto
city: Fushimi
country: Japan
facility: Kyoto Ohashi General Hospital
state: Kyoto
city: Joyo
country: Japan
facility: Houyu hospital
state: Kyoto
city: Maizuru
country: Japan
facility: National Hospital Organization Maizuru Medical Center
state: Kyoto
city: Nagaokakyo
country: Japan
facility: Saiseikai Kyoto Hospital
state: Kyoto
city: Nantan
country: Japan
facility: Nantan General Hospital
state: Kyoto
city: Uji
country: Japan
facility: Rokujizo Hospital
state: Kyoto
city: Uji
country: Japan
facility: Second Okamoto General Hospital
state: Kyoto
city: Yosano
country: Japan
facility: Kyoto Prefectural Yosanoumi Hospital
state: Kyoto
city: Nishinokyokurumazaka-cho
country: Japan
facility: Marutamachi Hospital
state: Nakagyou-ku Kyoto
city: Asahi-machi
country: Japan
facility: Osaka City University Hospital
state: Osaka Abeno-ku
city: Nakanoshima
country: Japan
facility: Sumitomo Hospital
state: Osaka Kita-ku
city: Moriguchi
country: Japan
facility: Matsushita Memorial Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Midorigaoka Hospital
state: Osaka
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
city: Ritto
country: Japan
facility: Saiseikai Shigaken Hospital
state: Shiga
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Takaoka
country: Japan
facility: Saiseikai Takaoka Hospital
state: Toyama
city: Takaoka
country: Japan
facility: Kouseiren Takaoka Hoapital
state: Toyama
city: Uozu
country: Japan
facility: Toyama Rosai Hospital
state: Toyama
city: Yatsuo
country: Japan
facility: Yatsuo General Hospital
state: Toyama
city: Gobou
country: Japan
facility: Kitade Hospital
state: Wakayama
city: Fukui
country: Japan
facility: Fukui Cardio Vascular Center
city: Fukui
country: Japan
facility: Fukui General Hospital
city: Fukui
country: Japan
facility: Fukui Saiseikai Hospital
city: Gifu
country: Japan
facility: Gifu Municipal Hospital
city: Gifu
country: Japan
facility: Gifu Prefectural General Medical Center
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Nishijin Hospital
city: Kyoto
country: Japan
facility: Kyoto First Red Cross Hospital
city: Nara
country: Japan
facility: Nara City Hospital
city: Osaka
country: Japan
facility: Osaka Railway hospital
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
Study officials:
affiliation: Hokuriku-Kinki Immunochemotherapy Study Group
name: Koichi Miwa, MD, PhD
role: STUDY_CHAIR
References:
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.
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.