TROG12.01 A Randomised Trial of Weekly Cetuximab and Radiation Versus Weekly Cisplatin and Radiation in Good Prognosis Locoregionally Advanced HPV-Associated Oropharyngeal Squamous Cell Carcinoma
Human Papilloma Virus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC) is
increasing in incidence and has an improved prognosis compared to other head and neck
malignancies when treated with standard combination chemoradiation.
The current standard regimen of high dose cisplatin and Radiation Therapy (RT) for head and
neck cancer patients results in significant toxicity and is at the limits of tolerance. The
excellent prognosis of patients with HPV-positive OPSCC raises concerns about overtreatment
with the current standard of care, resulting in unnecessary acute and late morbidity.
Therefore, investigation of chemo-sparing or chemo-modified regimens with RT for
HPV-associated OPSCC that do not compromise efficacy is warranted. A number of regimens less
intensive than high dose cisplatin are being used in clinical practice for patients with
good prognosis HPV OPSCC, but no comparative trials have been performed in this population.
The trial population will be restricted to low risk HPV-associated OPSCC.
A- RT (70 Gy in 35 fractions, 5 days a week over 7 weeks) with weekly Cetuximab (400 mg/m2
loading dose IV prior to radiation, followed by weekly cetuximab 250 mg/m2 for the duration
of the radiotherapy) B- RT(70 Gy in 35 fractions, 5 days a week over 7 weeks) with weekly
Cisplatin (40 mg/m2 IV for the duration of the radiotherapy)
Hypothesis: In patients with locally advanced HPV-associated OPSCC, those treated with
weekly cetuximab and conventionally fractionated radiotherapy will experience less acute
symptom severity than patients receiving weekly cisplatin and conventionally fractionated
Patients will be followed weekly during treatment, then at 1, 3, 5, 9, 13 weeks
post-treatment and at months 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 42, 48, 54, and 60
post-completion of treatment. Follow-up for the trial will cease when the last patient
accrued has a minimum of 2 years follow-up i.e. has attended the 24 months post-treatment
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The area under curve of symptom severity between weekly cisplatin and Radiotherapy Therapy (RT) versus weekly cetuximab and RT from baseline to week 20 (13 weeks post-completion of radiotherapy) as measured by M.D. Anderson Symptom Inventory - Head and Neck Module (MDASI-HN).
D Rischin, Dr
TROG and Peter MacCallum Cancer Centre
Australia: Department of Health and Ageing Therapeutic Goods Administration