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De-ESCALaTE

 Logo for DeESCALaTEDetermination of epidermal growth factor receptor-inhibitor (cetuximab)
versus standard chemotherapy (cisplatin) early and late toxicity events in human papillomavirus-positive oropharyngeal squamous cell carcinoma

 

Acronym:

De-ESCALaTE HPV

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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.

Eligibility:

Inclusion Criteria

• AJCC TNM Stage III-IVa [T3N0-T4N0, and T1N1-T4N3] oropharyngeal SCC tumours.

• Clinical multidisciplinary team decision to treat with primary curative chemoradiotherapy.
• No previous treatment for the primary tumour, including surgery, neck dissection or tracheostomy [except node biopsies or diagnostic tonsillectomy].

• Medically fit (ECOG 0, 1 or 2).

• Adequate cardiovascular, haematological, renal and hepatic function.

• Age > 18 years.

• Written informed consent given.

• Using adequate contraception [male and female participants]. Must take contraceptive measures during, and for at least six months after treatment.

Exclusion Criteria

• Distant metastasis (i.e. AJCC TNM stage IVc disease)

• AJCC TNM Stage T1-2N0 disease

• Treated with primary radical surgery to the primary site (e.g. resection)

• Concurrent use of CYP3A4 inducers or inhibitors. [A standard course of dexamethasone or aprepitant for the prevention of cisplatin-induced nausea and vomiting is permitted]

• Serious cardiac illness or other medical conditions precluding the use of cisplatin or cetuximab

• HPV+ patients who have p16+ tumours who also have N2b, N2c or N3 nodal disease and whose lifetime smoking history is also more than 10 pack years (i.e. have both risk factors)

• Pregnant or lactating

• Previous treatment for any other cancer with cytotoxics, radiotherapy or anti-EGFR therapies

• Inadequate renal, haematological or liver functions

• Patients with clinically significant hearing impairment

• Life expectancy less than 3 months

• Other malignancy within the past 3 years except basal cell skin cancer or preinvasive carcinoma of the cervix

Status:

Open

Lead Centre:

InHANSE

and

Warwick Clinical Trials Unit, University of Warwick  

 

Study Coordinator:

Tessa Fulton-Lieuw
De-ESCALaTE Coordinator

Warwick Clinical Trials Unit
Warwick Medical School
Division of Health Sciences
Gibbet Hill Campus
University of Warwick
Coventry
CV4 7AL

Tel: 0247 615 1722
Fax: 0247 615 1586
Email: 
m.t.ful[email protected]

Study Website:

www.warwick.ac.uk/go/deescalate
 

Charity appeal

Find out more about our £1m Charity appeal for the AcceleraTED cancer Treatment programme.