drugset / Trial / NCT00999700
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
RandomizedParallel-groupOpen-labelTreatment
Summary
A phase III trial of induction chemotherapy followed by definitive radiotherapy plus Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (HNC).
Timeline
- Start
- 2009-09
- Primary completion
- 2016-12-31
- Completion
- 2021-12
Publications
- Results - J.P. Pignon et al. Lancet 2000
- Results - A. Forastiere et al., New Engl J Med 2001
- Results - Adelstein DJ J.Clin.Oncol. 2003
- Results - Henke, New England 2004
- Results - J.A. Bonner et al., New Engl J Med 2006
- Results Merlano M. Alternating chemotherapy and radiotherapy in locally advanced head and neck cancer: an alternative? Oncologist. 2006 Feb;11(2):146-51. doi: 10.1634/theoncologist.11-2-146.
- Results - Posner M et al, New Engl J Med 2007
- Results - Vermorken J et al, New Engl J Med 2007
- Results - Lo Nigro, Journal of Cancer Research Clinical Oncology 2009
- Results Merlano M, Marchetti G. Radiochemotherapy in head and neck cancer. Cancer Treat Rev. 2003 Aug;29(4):291-6. doi: 10.1016/s0305-7372(03)00022-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Comparator | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 750 mg/m2 | — |