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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216034
• Other study ID #: HKIT-GC
• Status: Completed
• Phase: Phase 3
• First received: September 18, 2005
• Last updated: June 6, 2016
• Start date: March 2005
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: Hokuriku-Kinki Immunochemotherapy Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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
• Krestin (PSK)
From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day

Locations

Country	Name	City	State
Japan	Osaka City University Hospital	Asahi-machi	Osaka Abeno-ku
Japan	University of Fukui Hospital	Eiheiji	Fukui
Japan	Fukuchiyama City Hospital	Fukuchiyama	Kyoto
Japan	Fukui Cardio Vascular Center	Fukui
Japan	Fukui General Hospital	Fukui
Japan	Fukui Saiseikai Hospital	Fukui
Japan	Kyoto Ohashi General Hospital	Fushimi	Kyoto
Japan	Gifu Municipal Hospital	Gifu
Japan	Gifu Prefectural General Medical Center	Gifu
Japan	Gifu University Hospital	Gifu
Japan	Kitade Hospital	Gobou	Wakayama
Japan	Public Central Hospital of Matto Ishikawa	Hakusan	Ishikawa
Japan	Shimane University Hospital	Izumo	Shimane
Japan	Houyu hospital	Joyo	Kyoto
Japan	Ishikawa Prefectural Central Hospital	Kanazawa	Ishikawa
Japan	Kanazawa Redcross Hospital	Kanazawa	Ishikawa
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	Shakaihoken Kobe Central Hospital	Kobe	Hyogo
Japan	Kyoto First Red Cross Hospital	Kyoto
Japan	Nishijin Hospital	Kyoto
Japan	University Hospital, Kyoto Prefectural University of Medicine	Kyoto
Japan	National Hospital Organization Maizuru Medical Center	Maizuru	Kyoto
Japan	Matsushita Memorial Hospital	Moriguchi	Osaka
Japan	Saiseikai Kyoto Hospital	Nagaokakyo	Kyoto
Japan	Sumitomo Hospital	Nakanoshima	Osaka Kita-ku
Japan	Nantan General Hospital	Nantan	Kyoto
Japan	Nara City Hospital	Nara
Japan	Marutamachi Hospital	Nishinokyokurumazaka-cho	Nakagyou-ku Kyoto
Japan	Osaka Railway hospital	Osaka
Japan	Shiga University of Medical Science Hospital	Otsu	Shiga
Japan	Saiseikai Shigaken Hospital	Ritto	Shiga
Japan	Kouseiren Takaoka Hoapital	Takaoka	Toyama
Japan	Saiseikai Takaoka Hospital	Takaoka	Toyama
Japan	Midorigaoka Hospital	Takatsuki	Osaka
Japan	Toyama Prefectural Central Hospital	Toyama
Japan	National Hospital Organization Fukui Hospital	Tsuruga	Fukui
Japan	Kanazawa Medical University Hospital	Uchinada	Ishikawa
Japan	Rokujizo Hospital	Uji	Kyoto
Japan	Second Okamoto General Hospital	Uji	Kyoto
Japan	Toyama Rosai Hospital	Uozu	Toyama
Japan	Yatsuo General Hospital	Yatsuo	Toyama
Japan	Kyoto Prefectural Yosanoumi Hospital	Yosano	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Hokuriku-Kinki Immunochemotherapy Study Group

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of recurrence (calculation of 3-year disease-free survival and overall survival rates)		Five years after surgery	No
Secondary	Relations of survival rate with compliance, postoperative complication, QOL, adverse events, recurrence status, and expression of immune or tumor markers		Five years after surgery	Yes