Comparing radiotherapy and trans-oral surgery for HPV-negative oropharyngeal cancer
A Phase II Randomized Trial for HPV-Negative Oropharyngeal Squamous Cell Carcinoma: Radiotherapy vs. Trans-Oral Surgery (ORATOR)
PHASE2 · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · NCT04220749
This study is testing whether radiotherapy or trans-oral surgery works better as the first treatment for early-stage HPV-negative throat cancer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT04220749 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed HPV-negative oropharyngeal squamous cell carcinoma at T1 or T2 stages.
Not a fit: Patients with HPV-positive tumors or those with advanced-stage oropharyngeal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with HPV-negative oropharyngeal cancer.
How similar studies have performed: Previous studies have shown varying success with similar treatment comparisons, but this specific approach is novel in its randomized design for this patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
London, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Cancer, Oropharyngeal Squamous Cell Carcinoma, Radiotherapy, Trans-Oral Surgery, HPV-Negative, Randomized