drugset / Trial / NCT00468169
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.
Timeline
- Start
- 2006-07
- Primary completion
- 2012-08
- Completion
- 2012-11
Outcome
Missed primary endpoint
registry analysis (unspecified test); A: Cetuximab+FHX; p = 0.1225; Log Rank; note: Log-rank test comparing PFS between two treatment arms NCT00468169 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Subject | Hydroxyurea | Other / unclassified | 500 mg | Oral |
| Subject | fluorouracil | Small molecule | 600 mg/m2 | — |