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This study is a prospective phase II trial, designed to assess the efficacy and feasibility of adjuvant treatment deintensification guided by ctHPVDNA levels for patients with HPV+OPSCC who undergo transoral surgery and neck dissection.
Oropharyngeal squamous cell carcinoma (OPSCC), commonly known as throat cancer or tonsil cancer, has seen a dramatic rise in incidence over the last twenty years due to the increased incidence of human papillomavirus-positive (HPV) infection and * malignancy within the oropharynx.
The prevailing treatment philosophy within head and neck oncology is that deintensifying treatment could still provide equivalent oncologic outcomes, while further lowering toxicity profiles and improving functional outcomes to minimize the morbidity incurred by patients.
The next frontier in the treatment of HPV+ OPSCC, then, is the potential use of ctHPVDNA in the treatment personalization. Patients could be stratified into risk categories based on their ctHPVDNA levels, and in turn, receive a tailored treatment intensity accordingly.
The goal of this research study is to see if de-intensifying (stopping or scaling back) treatment still provides the same, or perhaps even better, results when compared to standard treatment when using your ctHPVDNA test results as a guide for your treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation | Experimental | Subjects with undetectable postoperative ctHPVDNA levels and either 4 or fewer nodes will have no further adjuvant treatment. |
|
| Adjuvant Radiation 30 Gray | Experimental | Subjects with undetectable postoperative ctHPVDNA levels after surgery, negative margins, and five or more positive nodes; or confirmed extranodal extension (ENE) (greater than 2 mm) will undergo deintensified radiation treatment of 30 gray. |
|
| Adjuvant Radiation 40 Gray | Experimental | Subjects with positive postoperative ctHPVDNA will undergo reimaging to evaluate for potentially operable disease, followed by appropriate surgery as indicated. If surgery is performed, repeat ctHPVDNA levels will be checked, and if then negative, subject will be placed in observation or 30 Gy of radiation depending on nodal status. If repeat ctHPVDNA level is positive, or subject has no obvious operable disease then subject will undergo 40 Gy of radiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NavDx | Diagnostic Test | NavDx is a clinically validated blood test to detect circulating tumor HPV DNA (ctHPVDNA). In this study, ctHPVDNA results, in conjuction with specimen analysis, will be used to assign post-surgical adjuvant treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | Time from surgery to first disease recurrence or death from any cause | Up to 24 months post initial surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Local-reginal Control | Number of subjects with no recurrence at primary oropharyngeal site or in the neck nodal basins | Up to 24 months post initial surgery |
| Overall Survival | Time from surgery to death from any cause |
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Inclusion Criteria:
Pre-Surgery
Post-Surgery
• Subjects with unknown primaries included if primary is definitively identified and resectable with negative margins or if the palatine and lingual tonsils are thoroughly resected and pathologically proven to be negative for a primary.
Exclusion Criteria:
Serious medical condition preventing general anesthesia for surgery.
History of previous head and neck radiation or previous head and neck cancer within 3 years.
Distant metastatic disease present.
Subjects with synchronous HPV+ oropharynx primaries
Prior invasive malignant disease within 3 years, with the exception of non-melanoma skin cancer and thyroid cancer, unless patient is deemed cured or disease free, in which case patient may be included in the study.
Lactating or pregnant women. Women of childbearing potential must have a negative pregnancy test on the day of surgery. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Azeezat Yekinni | Contact | 317-529-6883 | ayekinn@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Sim, MD | Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Joe and Shelly Schwarz Cancer Center | Recruiting | Carmel | Indiana | 46032 | United States |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D014067 | Tonsillar Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Adjuvant Radiation 30 Gray | Radiation | If undetectable postoperative ctHPVDNA levels and five or more positive nodes, or confirmed extranodal extension (ENE) (greater than 2 mm) deintensified radiation treatment of 30 gray. |
|
| Adjuvant Radiation 40 Gray | Radiation | If detectable postoperative ctHPVDNA, then reimage to evaluate for potentially operable disease, followed by appropriate surgery as indicated. If surgery is performed, repeat ctHPVDNA levels will be checked, and if then negative, subject will be placed in observation if N0 or N1 disease, and 30 Gy of radiation if N2 disease on final pathologic staging. If repeat ctHPVDNA level is positive, or shows no obvious operable disease, then subject will undergo 40 Gy of radiation. |
|
| Up to 24 months post initial surgery |
| Distant metastasis rates | Assessed by tissue diagnosis or radiographically of recurrent disease at sites away from the primary tumor and neck nodal basins | Up to 24 months post initial surgery |
| Adverse Events | Number of subjects that experience adverse events, grades 1-5, as assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) version 5.0 | up to 6 months post initial surgery |
| Swallowing-related Quality Of Life | Assessed using MD Anderson Dysphagia Inventory (MDADI) | 3 months, 6 months, 12 months, and 24 months post initial surgery |
| Gastrostomy tube dependence rates | Assessed by confirmation of feeding tube in-situ in subject and being utilized for nutrition | 12 and 24 months post intial surgery |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009959 | Oropharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |