Clinical trial · Interventional
Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
A Randomized Phase II-III Multicenter Trial of Docetaxel Plus Cisplatin and Docetaxel Plus 5-FU Versus Cisplatin Plus 5-FU in 1st Line Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.
- 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 the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.
Conditions
Conditions (3)
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 Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Neoplasm Recurrence, Local | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil (5-FU) | Drug | Fluorouracil | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| docetaxel (XRP6976) | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- docetaxel plus cisplatin
- description
- Taxotere 75 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by cisplatin 75 mg/m² administered as a 30-minute to 3-hour infusion on Day 1
- interventionNames
- Drug: docetaxel (XRP6976)
- Drug: cisplatin
- type
- ACTIVE_COMPARATOR
- label
- cisplatin plus 5-FU
- description
- Cisplatin 100 mg/m², 30-minute to 3-hour infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 1000 mg/m²/day from Day 1 to Day 5
- interventionNames
- Drug: cisplatin
- Drug: 5-fluorouracil (5-FU)
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Patients with histologically or cytologically documented squamous cell carcinoma of the head and neck (SCCHN) (eligible primary sites: oral cavity, oropharynx, hypopharyx, or larynx) presenting with locally recurrent and/or metastatic disease, with at least 1 unidimensionally or bidimensionally measurable lesion.
References
Publications (0)
Data not yet available