Clinical trial · Interventional
Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer
A Randomized, Multicenter, Open-label, Phase III Trial of Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected (D2) Gastric Cancer of Stage IIIB/IV (M0)
- 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)
Docetaxel was the first drug that showed survival benefits when added to the CF regimen, but it was very toxic. Docetaxel is also has a synergistic anti-cancer effect with S-1, in phase I/II studies. The use of a docetaxel plus S-1 combination as first-line chemotherapy for advanced gastric cancer achieved response rates of 46\~56% and a median survival time of 14.0\~14.3 months. Based upon this background, the aim of this study is to detect a significant increase in 3 year DFS of disease for the test group (DS) relative to the Control group (SP).
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 Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DS | Drug | — | UNRESOLVED |
| SP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DS(Docetaxel with S-1)
- description
- Docetaxel with S-1
- interventionNames
- Drug: DS
- type
- ACTIVE_COMPARATOR
- label
- SP(S-1 with cisplatin)
- description
- S-1 with cisplatin
- interventionNames
- Drug: SP
Primary outcomes (1)
- measure
- 3-year disease free survival(DFS)
- timeFrame
- 3 years
- description
- Tumor assessments with chest X-rays and CT or MRI scan will be done at 6 months after randomization (after the end of the treatment period), then every 3 months for the first 2 years after randomization and then every 6 months for coming 3 years then one year basis until completion of the study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven, Stage IIIb/ IIIc curatively resected gastric carcinoma * ECOG performance status 0-1 * Curatively resected advanced gastric cancer patients of stage IIIb/IIIc * D2 lymph node dissection with R0 surgery * Signed informed consent Exclusion Criteria: * Subjects with documented distant metastasis. * Malabsorption syndrome or disease significantly affecting gastrointestinal function * Patients with other uncontrolled systemic illness, e.g. infection, poorly controlled HTN * History of other malignancy. Subjects who have been disease-free for 5 years or subjects with successfully treated in situ carcinoma are eligible. * Subjects with preoperative/adjuvant other cancer treatment, such as chemotherapy, immunotherapy and radiotherapy
References
Publications (0)
Data not yet available