Clinical trial · Interventional
Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer
A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer
NCT00287768CI-TRIAL-00005113completedPhase 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)
The primary objective of this study is to compare median overall survival of the test arm (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent gastric cancer.
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 |
|---|---|---|---|
| docetaxel + S-1 | Drug | — | UNRESOLVED |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Docetaxel + S-1
- interventionNames
- Drug: docetaxel + S-1
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- S-1
- interventionNames
- Drug: S-1
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- median
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma * Subjects must be able to take orally * Measurable lesion and/or non-measurable lesion defined by RECIST * ECOG performance status ≦ 1 * Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3 * Creatine ≦ upper normal limit (UNL) * Total bilirubin ≦ 1.5 X UNL * AST, ALT and ALP ≦ 2.5 x UNL * No prior chemotherapy * Life expectancy estimated than 3 months * Written informed consent Exclusion Criteria: * Active double cancer * Gastrointestinal bleeding * Excessive amounts of ascites require drainage * Known brain metastases * Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0 * Pulmonary fibrosis, Intestinal pneumonitis * History of hypersensitivity to fluoropyrimidines, docetaxel or medications formulated with polysorbate 80 * Any previous chemotherapy or radiotherapy for AGC * Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant * Treatment with any investigational product during the last 4 weeks prior to study entry * Definite contraindications for the use of corticosteroids * Any subject judged by the investigator to be unfit for any reason to participate in the study
References
Publications (3)
- 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
- DERIVEDKoizumi W, Kim YH, Fujii M, Kim HK, Imamura H, Lee KH, Hara T, Chung HC, Satoh T, Cho JY, Hosaka H, Tsuji A, Takagane A, Inokuchi M, Tanabe K, Okuno T, Ogura M, Yoshida K, Takeuchi M, Nakajima T; JACCRO and KCSG Study Group. Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer: a randomized study (START). J Cancer Res Clin Oncol. 2014 Feb;140(2):319-28. doi: 10.1007/s00432-013-1563-5. Epub 2013 Dec 24. PMID 24366758
- DERIVEDFujii M; 0. Chemotherapy for advanced gastric cancer: ongoing phase III study of S-1 alone versus S-1 and docetaxel combination (JACCRO GC03 study). Int J Clin Oncol. 2008 Jun;13(3):201-5. doi: 10.1007/s10147-008-0775-1. Epub 2008 Jun 14. PMID 18553228