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
- American Joint Committee on Cancer (AJCC) TNM Stage III-IVa (T3N0-T4N0, and
T1N1-T4N3) oropharyngeal squamous cell carcinoma (SCC) tumours
- Clinical multidisciplinary team decision to treat with primary curative cisplatin
- No previous treatment including surgery, except node biopsies or diagnostic
- 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 three months after treatment.
- 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
- Serious cardiac illness or other medical conditions precluding the use of cisplatin
or cetuximab [no history of clinically significant cardiac disease, serious
arrhythmias, or significant conduction abnormalities; no uncontrolled seizure
disorder; no active neurologic disease; no neuropathy greater than grade 1]
- 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
- Pregnant or lactating
- Previous treatment for any other cancer with cytotoxics, radiotherapy or anti-EGFR
- Inadequate renal, haematological or liver functions [Absolute neutrophil count
<1,500/mm3; platelet count <100,000/mm3; WBC <3,000/mm3; haemoglobin <9 g/dL.
[Haemoglobin correction by transfusion permitted.] Bilirubin > 1.5 times upper limit
of normal (ULN); alkaline phosphatase > 2.5 times ULN; AST and ALT > 2.5 times ULN.
Creatinine > 1.5 mg/dL; Creatinine clearance < 60 mL/min]
- 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
pre-invasive carcinoma of the cervix.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Overall number of events of acute severe toxicity between treatment arms.
Overall number of events of late severe toxicity between treatment arms.
Quality of life outcomes assessed by EORTC QLQ C30 and HN35 between the two treatment arms.
Effect on swallowing of the two treatment arms (assessed by MDADI and by PEG or RIG utilisation rate at 1 and 2 years).
Cost-effectiveness of the two treatment arms (assessed by EuroQoL-5D).
Overall survival and recurrence between the two arms.