drugset / Trial / NCT01086826
Treatment of Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Phase 3
Completed
320 enrolled
Associazione Volontari Pazienti Oncologici
Mario Negri Institute for Pharmacological Research · collab
RandomizedFactorialOpen-labelTreatment
Summary
This is a randomized multicenter open label phase III factorial trial evaluating the 3 years OS in patients with locally advanced squamous cell carcinoma of head and neck treated with locoregional treatment (radiotherapy plus concomitant chemotherapy or cetuximab) with or without neoadjuvant chemotherapy.
Timeline
- Start
- 2008-03
- Primary completion
- 2014-04
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 20 mg/m2 | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 800 mg/m2 | Intravenous |