NCT04220749 Radiotherapy vs. Trans-Oral Surgery for HPV-Negative Oropharyngeal Squamous Cell Carcinoma
| NCT ID | NCT04220749 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2020-06-25 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 68 participants in total. It began in 2020-06-25 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomized phase II study is a formal comparison of radiotherapy versus trans-oral surgery as the primary treatment of HPV-negative patients with early-stage oropharyngeal carcinoma.
Eligibility 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
Contact & Investigator
Danielle MacNeil, M.D.
PRINCIPAL INVESTIGATOR
London Regional Cancer Program, London Health Sciences Centre
Frequently Asked Questions
Who can join the NCT04220749 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04220749 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04220749 currently recruiting?
Yes, NCT04220749 is actively recruiting participants. Contact the research team at susan.archer@lhsc.on.ca for enrollment information.
Where is the NCT04220749 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT04220749 clinical trial?
NCT04220749 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Danielle MacNeil, M.D. at London Regional Cancer Program, London Health Sciences Centre. The trial plans to enroll 68 participants.
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