Clinical trial · Interventional
TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN
NCT00539630CI-TRIAL-00000901completedPhase 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)
To describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU, versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy.
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 |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed
- timeFrame
- After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy.
Secondary outcomes (1)
- measure
- Pathologic response if clinical response of primary tumor is CR at the end of chemotherapy and end of concurrent chemo/ radiotherapy, biopsy of primary tumor site will be performed to evaluate pathologic response rate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven squamous cell carcinoma of the head and neck with locally advanced inoperable disease. * Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx , larynx or nasopharynx. * Patients are required to have at least one (bi-or uni-dimensionally) measurable lesion. * WHO performance status 0 or 1. * Adequate bone marrow, hepatic and renal functions. Exclusion Criteria: * Pregnant and lactating women * Previous chemotherapy * Previous radiotherapy for H\&N * Previous surgery for H\&N The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.