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NCT Number: NCT00216034

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fukui Cardio Vascular Center, Fukui-shi, Fukui, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tegafur-gimeracil-oteracil potassium (TS-1)

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

Other names: TS-1

Krestin (PSK)

Drug

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

Other names: PSK

Primary outcomes

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

    Time frame: Five years after surgery

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hokuriku-Kinki Immunochemotherapy Study Group

Other

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2005
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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