De-ESCALaTE HPV_Final Version 1.0_28 Oct 2011

• Research type

  Research Study

• Full title

  De-ESCALaTE HPV: 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

• IRAS ID

  84585

• Contact name

  Hisham Mehanna

• Eudract number

  2011-005165-21

• ISRCTN Number

  .

• Clinicaltrials.gov Identifier

  .

• Research 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 related OPSCC (HPV㣴) is considered a distinct disease entity, affecting younger patients and has a good prognosis following treatment. HPV㣴 appears to respond very well to many treatments such as platin chemo-radiotherapy (standard treatment), surgery and other types of chemoradiotherapy. However, treatment often involves considerable side effects and as this disease affects younger patients, there is the potential for patients to live with these side effects for several decades.Radiotherapy and cetuximab have demonstrated similar efficacy to platin chemoradiotherapy in head and neck cancer, but is potentially less toxic. In the De-ESCALaTE HPV trial, 304 patients with HPV㣴 will be recruited from multiple UK and international sites over three years. Patients will be randomised to receive either cisplatin radiotherapy (Arm A) or cetuximab radiotherapy (Arm B) and will be followed up for two years. Patients will also be asked to complete questionnaires at regular intervals and to donate tissue, oraflud and blood samples (sample donation is optional). Results from this trial will be used to determine the optimum treatment of this cancer, with the primary aim of decreasing toxicity and improving quality of life for HPV㣴 patients. Patients who give consent, but are confirmed to be HPV negative, and who will receive treatment according to Arm A, will be given the opportunity to enter the Registration Cohort Study (RCS). These patients will not be randomised to receive one of the two treatments, but will be asked to provide samples and complete Quality of Life questionnaires.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  11/WM/0381

• Date of REC Opinion

  29 Nov 2011

• REC opinion

  Favourable Opinion