Clinical trial · Interventional
Docetaxel, Oxaliplatin and S-1 (DOS) for Advanced Gastric Cancer
A Phase II Study of Docetaxel, Oxaliplatin and S-1 (DOS) in Patients With Advanced Gastric Cancer
NCT00525005CI-TRIAL-00008055completedPhase 2ClinicalTrials.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 purpose of this study is to determine the efficacy of combination of docetaxel, oxaliplatin, and S-1 (DOS) in the treatment of advanced 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 |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DOS (Docetaxel, Oxaliplatin and S-1) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DOS (Docetaxel, Oxaliplatin and S-1)
- description
- Docetaxel 52.5mg/m2 IV on D1 (diluted in 250 ml of normal saline over a 1 hour of each cycle before oxaliplatin) Oxaliplatin 105mg/m2 IV on D1 (diluted in 250 ml of 5% DW for 2 hours) S-1 80mg/m2/day on D1-14 (2 weeks of treatment followed by a 1-week rest period)
- interventionNames
- Drug: DOS (Docetaxel, Oxaliplatin and S-1)
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- 2.5 years
Secondary outcomes (1)
- measure
- safety, progression-free survival, and overall survival
- timeFrame
- 2.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed gastric adenocarcinoma, initially diagnosed or recurred * Unresectable, locally advanced or metastatic * At least one uni-dimensional measurable lesion by RECIST criteria * Age 18 to 70 years old * ECOG performance status ≤2 * Estimated life expectancy ≥3 months * Adequate bone marrow function (WBCs ≥4,000/µL or absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL), * Adequate kidney function (creatinine \<1.5 mg/dL) * Adequate liver function (bilirubin ≤1.8 mg/dL, transaminase levels \<2 times the upper normal limit * Written informed consent Exclusion Criteria: * Other tumor type than adenocarcinoma * Previous history of chemotherapy (exception: adjuvant chemotherapy) * Presence of CNS metastasis, psychosis, or seizure * Obvious bowel obstruction * Evidence of serious gastrointestinal bleeding * Peripheral neuropathy (NCI CTC \>= Grade I) * Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri * Pregnant or lactating women, women of childbearing potential not employing adequate contraception * Other serious illness or medical conditions
References
Publications (6)
- BACKGROUNDYamaguchi K, Shimamura T, Hyodo I, Koizumi W, Doi T, Narahara H, Komatsu Y, Kato T, Saitoh S, Akiya T, Munakata M, Miyata Y, Maeda Y, Takiuchi H, Nakano S, Esaki T, Kinjo F, Sakata Y. Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer. Br J Cancer. 2006 Jun 19;94(12):1803-8. doi: 10.1038/sj.bjc.6603196. PMID 16773074
- BACKGROUNDYoshida K, Ninomiya M, Takakura N, Hirabayashi N, Takiyama W, Sato Y, Todo S, Terashima M, Gotoh M, Sakamoto J, Nishiyama M. Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer. Clin Cancer Res. 2006 Jun 1;12(11 Pt 1):3402-7. doi: 10.1158/1078-0432.CCR-05-2425. PMID 16740764
- BACKGROUNDZang DY, Yang DH, Lee HW, Hwang SW, Song HH, Jung JY, Kwon JH, Kim HJ, Kim JH, Park SR, Kim MJ, Jang KM, Park CK, Kim JH, Lee BH. Phase I/II trial with docetaxel and S-1 for patients with advanced or recurrent gastric cancer with consideration to age. Cancer Chemother Pharmacol. 2009 Feb;63(3):509-16. doi: 10.1007/s00280-008-0768-9. Epub 2008 May 15. PMID 18481067
- BACKGROUNDRichards D, Wilfong L, Sborov M, McCollum D, Khan M, Boehm K, Zhan F. Phase II trial of docetaxel+oxaliplatin in advanced gastroesophageal and/or stomach cancer. 7th World Congr Gastrointest cancer. 2005: Abs: P-143
- BACKGROUNDBarone C, Basso M, Schinzari G, Pozzo C, Trigila N, D'Argento E, Quirino M, Astone A, Cassano A. Docetaxel and oxaliplatin combination in second-line treatment of patients with advanced gastric cancer. Gastric Cancer. 2007;10(2):104-11. doi: 10.1007/s10120-007-0415-x. Epub 2007 Jun 25. PMID 17577620
- BACKGROUNDZang D, Yang D, Lee H, Lee B, Hwang S, Kim H, Song H, Jung J, Kim J, Kwon J. Phase I study of docetaxel, oxalipaltin and S-1 (DOS) for patients with advanced gastric cancer. Ann Oncol 2007 Sep 23; Abs:in press