HPV-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) is a type of cancer that affects parts of the throat, like the tonsils and the base of the tongue. The treatments for OPSCC, which may include surgery, radiation, and chemotherapy, often cause serious side effects, such as loss of taste, dry mouth, and long-term problems with swallowing. These side effects can lower patients' quality of life and make it difficult for them to eat and speak normally.
This study aims to explore whether using lower doses of radiation after surgery can help improve long-term swallowing function in patients with HPV-positive OPSCC. By doing this, the study team hopes to reduce treatment-related side effects while maintaining good cancer control.
Histologically confirmed or suspected HPV associated squamous cell carcinoma of the oropharynx.
p16 immunohistochemistry is the surrogate marker for HPV positivity and will be scored as positive if there is strong and diffuse nuclear and cytoplasmic staining present in greater than 70% of the tumor specimen. (A negative result excludes the patient from the trial)
In the case of equivocal p16, High Risk HPV (HR HPV), In-Situ Hybridization (ISH) / Polymerase Chain Reaction (PCR) may be performed to determine HPV positivity
AJCC TNM 7th edition stage T1-T3, N0-N2b (or AJCC TNM 8th edition stage T1-T3 N0-N1) disease.
HPV negative squamous cell carcinomas of the head and neck
T4 and/or T1-T3 tumors where transoral surgery is considered not feasible or there is a high likelihood of positive margins.
AJCC TNM 7th edition N2c-N3 nodal disease (or AJCC TNM 8th edition N2-N3 nodal disease) or high likelihood of gross extranodal extension.
Patients for whom transoral surgery and neck dissection is not considered the primary treatment modality.
Parallel
de-intensified radiation
RadiationAdjuvant radiation will be administered on a de-intensified schedule.
Assess oncologic outcomes of a de-intensified post-surgical adjuvant treatment by measuring overall survival.
Overall survival will be monitored.
Safety and tolerability
The study will use the CTCAE version 5.0 for reporting of non-hematologic adverse events.
Assess oncologic outcomes of a de-intensified post-surgical adjuvant treatment by measuring progression free survival.
Assess oncologic outcomes of a de-intensified post-surgical adjuvant treatment by measuring progression free survival.
Assess oncologic outcomes of a de-intensified post-surgical adjuvant treatment by measuring locoregional control.
Locoregional control (LRC) is defined as time from treatment initiation to local or regional recurrence
Evaluate how changes in serum HPV ctDNA are associated\ with HPV-positive OPSCC recurrence
ctDNA will be measured at baseline and at several points during follow-up. The sensitivity, specificity and concordance of the HPV ctDNA results in relation to the clinical and pathologic disease status (presence/absence) will be corelated.
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This trial is not recruiting at the moment. You can still explore other options:
