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

NCT ID: NCT00216034

Last Updated: 2016-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2016-02-29

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

Tegafur-gimeracil-oteracil potassium (TS-1)

Intervention Type: DRUG

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

2

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

Group Type: EXPERIMENTAL

Tegafur-gimeracil-oteracil potassium (TS-1)

Intervention Type: DRUG

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)

Intervention Type: DRUG

From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day

Interventions

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

Intervention Type: DRUG

Krestin (PSK)

From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day

Intervention Type: DRUG

Other Intervention Names

TS-1; PSK

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hokuriku-Kinki Immunochemotherapy Study Group

OTHER

Sponsor Role: lead

Responsible Party

Takashi Fujimura

Assistant Professor of Gastroenterologic Surgery, Kanazawa University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Koichi Miwa, MD, PhD

Role: STUDY_CHAIR

Hokuriku-Kinki Immunochemotherapy Study Group

Locations

Fukui Cardio Vascular Center

Fukui-shi, Fukui, Japan

Fukui General Hospital

Fukui-shi, Fukui, Japan

Fukui Saiseikai Hospital

Fukui-shi, Fukui, Japan

University of Fukui Hospital

Iijima, Fukui, Japan

National Hospital Organization Fukui Hospital

Tsuruga, Fukui, Japan

Gifu Municipal Hospital

Gifu, Gifu, Japan

Gifu Prefectural General Medical Center

Gifu, Gifu, Japan

Gifu University Hospital

Gifu, Gifu, Japan

Shakaihoken Kobe Central Hospital

Kobe, Hyōgo, Japan

Public Central Hospital of Matto Ishikawa

Hakusan, Ishikawa-ken, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, Japan

Kanazawa Redcross Hospital

Kanazawa, Ishikawa-ken, Japan

Kanazawa Medical University Hospital

Mukai-awagasaki, Ishikawa-ken, Japan

Fukuchiyama City Hospital

Fukuchiyama, Kyoto, Japan

Kyoto Ohashi General Hospital

Fushimi, Kyoto, Japan

Houyu hospital

Jōyō, Kyoto, Japan

Saiseikai Kyoto Hospital

Kōtari, Kyoto, Japan

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Nishijin Hospital

Kyoto, Kyoto, Japan

Kyoto First Red Cross Hospital

Kyoto, Kyoto, Japan

National Hospital Organization Maizuru Medical Center

Maizuru, Kyoto, Japan

Nantan General Hospital

Nantan, Kyoto, Japan

Rokujizo Hospital

Uji, Kyoto, Japan

Second Okamoto General Hospital

Uji, Kyoto, Japan

Kyoto Prefectural Yosanoumi Hospital

Yotsutsuji, Kyoto, Japan

Marutamachi Hospital

Nishinokyokurumazaka-cho, Nakagyou-ku Kyoto, Japan

Nara City Hospital

Nara, Nara, Japan

Matsushita Memorial Hospital

Moriguchi, Osaka, Japan

Osaka Railway hospital

Osaka, Osaka, Japan

Midorigaoka Hospital

Takatsuki, Osaka, Japan

Osaka City University Hospital

Kembuchi, Osaka Abeno-ku, Japan

Sumitomo Hospital

Nakanoshima, Osaka Kita-ku, Japan

Shiga University of Medical Science Hospital

Ōtsu, Shiga, Japan

Saiseikai Shigaken Hospital

Rittō, Shiga, Japan

Shimane University Hospital

Izumo, Shimane, Japan

Saiseikai Takaoka Hospital

Takaoka, Toyama, Japan

Kouseiren Takaoka Hoapital

Takaoka, Toyama, Japan

Toyama Prefectural Central Hospital

Toyama, Toyama, Japan

Toyama Rosai Hospital

Uozu, Toyama, Japan

Yatsuo General Hospital

Yatsuomachi-higashikumisaka, Toyama, Japan

Kitade Hospital

Gobou, Wakayama, Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 7910230 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 16803844 (View on PubMed)

Other Identifiers

HKIT-GC

Identifier Type: -

Identifier Source: org_study_id