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New treatment option for Head and Neck Cancer
Official title Radiotherapy vs. Trans-Oral Surgery for HPV-Negative Oropharyngeal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT04220749
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.