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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


Phase 3
20 Years
80 Years
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Five years after surgery

Safety Issue:

No

Principal Investigator

Koichi Miwa, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hokuriku-Kinki Immunochemotherapy Study Group

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

HKIT-GC

NCT ID:

NCT00216034

Start Date:

March 2005

Completion Date:

February 2016

Related Keywords:

  • Gastric Cancer
  • Gastric Cancer
  • TS-1
  • PSK
  • Disease-free survival
  • Overall survival
  • Stomach Neoplasms

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