A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)
Inclusion Criteria:
- age 18 or older
- willing to provide informed consent
- ECOG performance status 0-2
- Histologically confirmed squamous cell carcinoma primary rumour site in the
oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
- Tumour stage:T1 or T2, with likely negative resections at surgery
- Nodal stage: N0, N1 (<=3cm), or N2 (up to 2 nodes between 1-3cm, on either side of
the neck), without extranodal extension on pre-randomization imaging.
- Patient assessed at head and neck multidisciplinary clinic (with assessment by
radiation oncologist and surgeon) and presented at multidisciplinary tumour board
prior to randomization.
Exclusion Criteria:
- Serious medical comorbidities or other contraindications to radiotherapy,
chemotherapy or surgery
- Prior history of head and neck cancer within 5 years
- Prior head and neck radiation at any time
- Metastatic disease
- Inability to attend full course of radiotherapy or follow-up visits
- Neck disease with unknown primary site
- Prior invasive malignant disease unless disease-free for at least 5 years or more,
with the exception of non-melanoma skin cancer
- unable or unwilling to complete QoL questionnaires