ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx

Part of paid clinical trials in Carmel, Indiana.

Sponsor
Indiana University
Study ID
NCT06915038
Status
Recruiting
Apply to this trial

Conditions

  • HPV Positive Cancer
  • Squamous Cell Carcinoma of Oropharynx
  • Throat Cancer
  • Tonsil Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 11, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Observation
    Subjects with undetectable postoperative ctHPVDNA levels and either 4 or fewer nodes will have no further adjuvant treatment.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Disease Free Survival [ Time Frame: Up to 24 months post initial surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
IU Health Joe and Shelly Schwarz Cancer CenterCarmelIndiana46032
Sarah Dutkevitch, RN
[email protected]
317-278-5618
Michael Sim, MD (PRINCIPAL_INVESTIGATOR)
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Azeezat Yekinni
[email protected]
317-529-6883
Michael Sim, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Carmel, IN

By research site
IU Health Joe and Shelly Schwarz Cancer Center· Carmel, INIndiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, IN

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