Clinical trial · Interventional
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
NCT00216034CI-TRIAL-00022506completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Krestin (PSK) | Drug | — | UNRESOLVED |
| Tegafur-gimeracil-oteracil potassium (TS-1) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- TS-1 Group: The group treated with TS-1 mono-therapy
- interventionNames
- Drug: Tegafur-gimeracil-oteracil potassium (TS-1)
- type
- EXPERIMENTAL
- label
- 2
- description
- TS-1+PSK Group: The group treated with combination therapy using TS-1 and PSK
- interventionNames
- Drug: Tegafur-gimeracil-oteracil potassium (TS-1)
- Drug: Krestin (PSK)
Primary outcomes (1)
- measure
- Time of recurrence (calculation of 3-year disease-free survival and overall survival rates)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDNakazato 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. PMID 7910230
- DERIVEDUeda 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. PMID 16803844