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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takashi Fujimura, Hokuriku-Kinki Immunochemotherapy Study Group
ClinicalTrials.gov Identifier:
NCT00216034
First received: September 18, 2005
Last updated: March 20, 2012
Last verified: March 2012

September 18, 2005
March 20, 2012
March 2005
February 2016   (final data collection date for primary outcome measure)
Time of recurrence (calculation of 3-year disease-free survival and overall survival rates) [ Time Frame: Five years after surgery ] [ Designated as safety issue: No ]
Time of recurrence (calculation of 3-year disease-free survival and overall survival rates)
Complete list of historical versions of study NCT00216034 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Relations of survival rate with compliance, postoperative complication, QOL, adverse events, recurrence status, and expression of immune or tumor markers
Not Provided
Not Provided
 
Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • 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
    Other Name: TS-1
  • Drug: Krestin (PSK)
    From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day
    Other Name: PSK
  • Active Comparator: 1
    TS-1 Group: The group treated with TS-1 mono-therapy
    Intervention: Drug: Tegafur-gimeracil-oteracil potassium (TS-1)
  • Experimental: 2
    TS-1+PSK Group: The group treated with combination therapy using TS-1 and PSK
    Interventions:
    • Drug: Tegafur-gimeracil-oteracil potassium (TS-1)
    • Drug: Krestin (PSK)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
280
February 2016
February 2016   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00216034
HKIT-GC
Yes
Takashi Fujimura, Hokuriku-Kinki Immunochemotherapy Study Group
Hokuriku-Kinki Immunochemotherapy Study Group
Not Provided
Study Chair: Koichi Miwa, MD, PhD Hokuriku-Kinki Immunochemotherapy Study Group
Hokuriku-Kinki Immunochemotherapy Study Group
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP