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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very Low Risk | No Intervention | Patients with T1-T2 tumors which exhibit no adverse histological features (must have all of the following: negative margins, no perineural invasion or vascular invasion, 1 or fewer lymph nodes with metastasis ≤3 cm in size, negative for extranodal extension). Patients in this group will not receive any adjuvant treatment per standard of care. | |
| Low Risk | Experimental | Patients with T1-T2 tumors which exhibit no adverse histological features (must have all of the following: negative margins, no perineural invasion or vascular invasion), 2 lymph nodes with metastasis and/or lymph node metastasis 3.1-4cm in size, negative for extranodal extension, not "positive" or "intermediate" HPV ctDNA post-surgery. Patients in this group will not receive any adjuvant treatment. This is a de-intensified treatment, since NCCN guidelines recommend adjuvant radiation 60Gy for patients with a nodal metastasis greater than 3 cm in size or if there are multiple positive nodes |
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| Intermediate Risk | Experimental | Patients with any of the following - T3 tumors or T1-T2 tumors with additional risk factors (perineural invasion or vascular invasion), lymph node involvement greater than 4cm in size or with minimal extranodal extension (1-2mm), 3 or more lymph nodes with metastasis, "intermediate" or "positive" HPVctDNA post-surgery. Patients in this group will receive adjuvant radiation therapy at a de-intensified dose of 50Gy (as opposed to standard dose of 60Gy). |
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| High Risk | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| de-intensified radiation | Radiation | Adjuvant radiation will be administered on a de-intensified schedule. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess oncologic outcomes of a de-intensified post-surgical adjuvant treatment by measuring overall survival. | Overall survival will be monitored. | from enrollment to 5 year follow-up |
| Safety and tolerability | The study will use the CTCAE version 5.0 for reporting of non-hematologic adverse events. | from enrollment to 5 year follow-up |
| 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. | from enrollment to 5 year follow-up |
| 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 | from enrollment to 5 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from enrollment to 5 year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mirabelle Sajisevi, MD | Contact | (802) 847-4535 | Mirabelle.sajisevi@uvmhealth.org | |
| Havaleh Gagne, MD | Contact | (802) 656-4414 | Havaleh.gagne@uvmhealth.org |
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Patients will be stratified into 4 groups depending on their risk factors. Groups A and be will not receive radiation (de-intensified), group C will receive a de-intensified level of radiation, group D will receive standard of care radiation (not de-intensified).
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Patients with tumors of any T or any N stage, which exhibit grossly positive margins or extensive extranodal extension. Patients in this group will receive standard of care treatment (per physician discretion, usually involves chemoradiation). Treatment for this group is not part of the protocol. Patient can elect to enroll on the imaging/HPV ctDNA surveillance component of the trial. Since this is not a de-intensified regimen, every effort will be made to reduce the number of patients in the high-risk category through careful baseline clinical exam and evaluation of imaging. In patients whom there is a concern for gross extranodal extension or that surgery will result in a grossly positive margin, they will be recommended to undergo a non-surgical route in order to avoid triple modality therapy.
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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