Clinical trial · Interventional
Docetaxel and S-1 for Advanced Esophageal Cancer
A Phase II Study of Docetaxel and S-1 as First-line Chemotherapy in Patients With Advanced Esophageal Cancer
NCT01693432CI-TRIAL-00029217unknownPhase 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)
This study will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean patients with esophageal 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 |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DS (docetaxel+S-1) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DS (docetaxel+S-1)
- description
- Treatment will be delivered as a 3-week cycle. 1. Docetaxel 60 mg/m²IV on day 1 2. S-1 80 mg/m2/day PO on day 1-14
- interventionNames
- Drug: DS (docetaxel+S-1)
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 1.5 years
- description
- Objective response rate will be measured from the rate of complete response (disappearance of disease) and partial response (decrease at least 30% in the sum of the longest diameters of target lesions) by RECIST (response evaluation criteria in solid tumors) guidelines.
Secondary outcomes (4)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed squamous cell carcinoma or adenocarcinoma of esophagus. * Unresectable locally advanced, recurrent or metastatic disease. * Measurable or evaluable disease by RECIST criteria 1.1. * Minimum age of 18 years. * ECOG Performance status 0-2. * Prior chemotherapy is not allowed. * More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions are outside the radiation field) * Adequate organ functions * Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital Exclusion Criteria: * Other tumor type than squamous cell carcinoma and adenocarcinoma * Previous history of chemotherapy except neoadjuvant or adjuvant chemotherapy without docetaxel and S-1 * Obvious bowel obstruction unrelieved by proper management * Evidence of serious gastrointestinal bleeding * Patients with CNS metastases * Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding * Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix * Known history of cerebral or leptomeningeal metastases or neurologic disease
References
Publications (0)
Data not yet available
No reference posted for this study.