Comparing radiotherapy and trans-oral surgery for HPV-negative oropharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase II study aims to compare the effectiveness of radiotherapy versus trans-oral surgery as primary treatments for early-stage HPV-negative oropharyngeal squamous cell carcinoma. Patients will be randomly assigned to either standard care or the experimental surgical approach in a 1:1 ratio, with stratification based on tumor and nodal stages. The study will assess progression-free survival, quality of life, overall survival, and treatment toxicity, providing critical data for potential future phase III trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older
* Willing to provide informed consent
* ECOG performance status 0-2
* Histologically confirmed squamous cell carcinoma
* HPV-negative tumor, as determined by: negative p16 status, real time PCR or in-situ hybridization. Central confirmation is not required prior to randomization. Equivocal/uncertain HPV status will be allowed on trial.
* Primary tumor site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
* Tumor stage: T1 or T2, with likely negative resection margins at surgery
* Nodal stage: N0-3. Patients with positive nodal disease and extranodal extension on imaging may be included at the surgeon's discretion, if the nodal disease is deemed resectable by the operating surgeon.
* Eligible for curative intent treatment, with likely negative resection margins at surgery. For patients where adequate transoral access is in question, they will first undergo an examination under anesthesia prior to randomization to ensure adequate exposure can be obtained.
* Blood work obtained within 4 weeks prior to randomization, with adequate bone marrow function, hepatic, and renal function, as determined by the investigator.
* Patient assessed by a radiation oncologist and surgeon and presented at multidisciplinary tumor board prior to randomization. If not feasible, case can be discussed with study Principal Investigator.

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
* 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
* Pregnant or lactating women

Where it's running

• London Regional Cancer Program
  London, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Danielle MacNeil, M.D. — London Regional Cancer Program, London Health Sciences Centre
• Study coordinator: Susan Archer
• Email: susan.archer@lhsc.on.ca
• Phone: 519-685-8618

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.