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

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Contents

Study summaryTimelineTable: Further ResourcesReferences
clinicaltrials.gov/study/NCT01874171
Is a
‌
Clinical study
1

Clinical Study attributes

NCT Number
NCT018741711
Trial Recruitment Size
3341
Trial Sponsor
University of Warwick
University of Warwick
1
Trial Collaborator
University of Oxford
University of Oxford
1
Cancer Research UK
Cancer Research UK
1
University of Birmingham
University of Birmingham
1
Clinical Trial Start Date
November 15, 2012
1
Primary Completion Date
2019
1
Study Completion Date
2019
1
Clinical Trial Study Type
Interventional1
Interventional Trial Purpose
Treatment1
Intervention Type
Drug1
Intervention Name
Cetuximab1
Cisplatin1
Interventional Trial Phase
Phase 31
Participating Facility
Musgrove Park Hospital
Musgrove Park Hospital
1
Queen Elizabeth Hospital Birmingham
Queen Elizabeth Hospital Birmingham
1
Western General Hospital
Western General Hospital
1
James Cook University Hospital
James Cook University Hospital
1
Aberdeen Royal Infirmary
Aberdeen Royal Infirmary
1
Royal United Hospital
Royal United Hospital
1
‌
Glan Clwyd Hospital
1
VU University Medical Center
VU University Medical Center
1
...
Official Name
Determination of Epidermal Growth Factor Receptor-inhibitor (Cetuximab) Versus Standard Chemotherapy (Cisplatin) Early And Late Toxicity Events in Human Papillomavirus-positive Oropharyngeal Squamous Cell Carcinoma1
Last Updated
May 8, 2017
1
Allocation Type
Randomized1
Intervention Model
Parallel Assignment1
Masking Type
None (Open Label)1
Study 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.

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Further Resources

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