NCT01874171

Determination of Cetuximab Versus Cisplatin Early and Late Toxicity Events in HPV+ OPSCC

Determination of Epidermal Growth Factor Receptor-inhibitor (Cetuximab) Versus Standard Chemotherapy (Cisplatin) Early And Late Toxicity Events in Human Papillomavirus-positive Oropharyngeal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: University of Warwick · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Oropharyngeal squamous cell carcinoma (OPSCC) incidence is increasing rapidly in the developed world. This has been attributed to a rise in Human Papillomavirus (HPV) infection. HPV+OPSCC is considered a distinct disease entity, affecting younger patients and has a good prognosis following treatment. Subsequently, patients can live with the considerable side effects for several decades. Radiotherapy and cetuximab (Epidermal Growth Factor Receptor-inhibitor) have demonstrated similar efficacy to 'platin' chemoradiotherapy (current standard treatment containing platinum-based compounds) in head and neck cancer, but is potentially less toxic. Results of this trial will be used to determine the optimum treatment of this debilitating cancer, with the primary aim of decreasing toxicity and improving quality of life for HPV+OPSCC patients.

Conditions

• Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin
DRUG	Cetuximab

Timeline

• Start date: 2012-11-15
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2013-06-10
• Last updated: 2017-05-08

Locations

33 sites across 3 countries: Ireland, Netherlands, United Kingdom