Clinical trial · Interventional
Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer
NCT00150670CI-TRIAL-00005178completedPhase 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)
This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone.
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 |
|---|---|---|---|
| TS-1 | Drug | — | UNRESOLVED |
| TS-1 and cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- TS-1 and cisplatin
- interventionNames
- Drug: TS-1 and cisplatin
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- TS-1
- interventionNames
- Drug: TS-1
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- every course for first three courses, then every other course
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma * Unresectable and recurrent gastric cancer * Age 20 to 74 * Performance status 0, 1, or 2 (ECOG) * Life expectancy 3 months * No prior chemotherapy or radiotherapy for gastric cancer * Able to take oral medication * Evaluable or not evaluable lesion had already checked more than 28 days before participated in this study * Hematopoietic Absolute granulocyte count lower limit of normal-12,000/mm\^3 Platelet ≥ 100,000/mm\^3 Hemoglobin ≥ 8.0 g/dL * Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL * Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 50 mL/min Exclusion Criteria: * Pregnant or nursing * Bleeding from gastrointestinal tract or no diarrhea * Hypersensitivity to TS-1 or CDDP * Psychiatric disorder that would preclude study compliance or giving informed consent * Severe acute or chronic medical or psychiatric condition or laboratory abnormality * Serious illness or medical condition * Brain metastasis * Ascites requiring drainage
References
Publications (2)
- RESULTKoizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008 Mar;9(3):215-21. doi: 10.1016/S1470-2045(08)70035-4. Epub 2008 Feb 20. PMID 18282805
- DERIVEDArai H, Takeuchi M, Ichikawa W, Shitara K, Sunakawa Y, Oba K, Koizumi W, Sakata Y, Furukawa H, Yamada Y, Takeuchi M, Fujii M. Correlation of multiple endpoints in the first-line chemotherapy of advanced gastric cancer: Pooled analysis of individual patient data from Japanese Phase III trials. Cancer Med. 2024 Jan;13(1):e6818. doi: 10.1002/cam4.6818. Epub 2023 Dec 23. PMID 38140879