Clinical trial · Interventional
Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)
A Randomized, Multicenter, Phase II Study of Docetaxel and TS-1 Combination as a First-line Treatment in Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT00805012CI-TRIAL-00005286terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual rate
Summary
Brief summary (as posted)
To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma
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 |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel+CDDP | Drug | — | UNRESOLVED |
| docetaxel+S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- docetaxel+CDDP
- interventionNames
- Drug: docetaxel+CDDP
- type
- EXPERIMENTAL
- label
- 2
- description
- docetaxel+S-1
- interventionNames
- Drug: docetaxel+S-1
Primary outcomes (1)
- measure
- Response rate
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed HNSCC * adequate primary site: oral cavity, oropharynx, hypopharynx, nasal cavity, paranasal sinus, other head and neck site (except nasopharynx) * at least one measurable lesion * no previous palliative chemotherapy (adjuvant/neoadjuvant chemotherapy and/or radiotherapy longer than 6 months ago is permitted) * 18 years or older * ECOG 0 or 1 * adequate laboratory result * written, informed consent Exclusion Criteria: * pregnant or lactating women (negative pregnancy test within 7 days is required for women with potential of child-bearing) * experimental drug clinical trial within 30 days * other malignancy (exemption: treated basal cell carcinoma of skin, CIS, cured cancer with disease-free interval with more than 5 years) * patient with organ transplantation * grade 2 or more peripheral neuropathy * grade 2 or more hearing loss * severe, medical condition
References
Publications (0)
Data not yet available
No reference posted for this study.