ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx
NCT ID: NCT06915038
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-06-11
2028-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Observation
Subjects with undetectable postoperative ctHPVDNA levels and either 4 or fewer nodes will have no further adjuvant treatment.
NavDx
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.
Adjuvant Radiation 30 Gray
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.
NavDx
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.
Adjuvant Radiation 30 Gray
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
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.
NavDx
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.
Adjuvant Radiation 40 Gray
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.
Interventions
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NavDx
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.
Adjuvant Radiation 30 Gray
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
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.
Eligibility Criteria
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Inclusion Criteria
* Subjects ≥ 18 years old at the time of informed consent.
* Ability to provide written informed consent and HIPAA authorization.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx).
* Histopathologically confirmed squamous cell carcinoma.
* Detectable ctHPVDNA from blood samples collected prior to treatment.
* Resectable and accessible tumor with high probability of achieving negative margins.
* Smokers and non-smokers included.
* Tumor stage (AJCC 8th edition): T1 or T2, and select T3 tumors that are mobile and do not invade the larynx.
* Nodal stage (AJCC 8th edition): N0, N1 or N2.
* Mobile neck nodes on physical exam if N positive.
* HPV+ tumor, as determined by p16, in-situ hybridization, real-time polymerase chain reaction, or ctHPVDNA.
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
* 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:
1. Has undergone a hysterectomy or bilateral oophorectomy; or
2. Has been naturally amenorrheic for at least 12 consecutive months.
18 Years
ALL
No
Sponsors
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Indiana University
OTHER
Responsible Party
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Michael W. Sim
Associate Professor, Department of Otolaryngology-Head & Neck Surgery
Principal Investigators
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Michael Sim, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Locations
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IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTO-IUSCCC-0895
Identifier Type: -
Identifier Source: org_study_id
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