HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Virginia
Study ID
NCT05962242
Phase
PHASE2
Status
Recruiting
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Conditions

  • Squamous Cell Carcinoma of the Oropharynx

Eligibility Criteria

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

Interventions

  • Radiation Therapy — RADIATION
    External Beam Radiation to Head and Neck

Study Details

The study will evaluate the safety and effectiveness of a lower than standard dose of radiation for definitive or adjuvant treatment of head and neck squamous cell carcinomas.

Key Dates

Start date
Jun 28, 2024
Status verified
Feb 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Reduce Dose without Concurrent Chemotherapy Non- Rapid Responder
    A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 36 Gy in 18 fractions to entire volume. Non-responders will receive an additional boost of 10 Gy in 5 fractions to entire volume.
  • Experimental: Reduce Dose with Concurrent Chemotherapy Non-Rapid Responder
    A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 30 Gy in 15 fractions to entire volume. Non-responders will receive an additional boost of 10 Gy in 5 fractions to entire volume.
  • Experimental: Reduce Dose without Concurrent Chemotherapy Rapid Responder
    A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 36 Gy in 18 fractions to entire volume.
  • Experimental: Reduce Dose with Concurrent Chemotherapy Rapid Responder
    A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 30 Gy in 15 fractions to entire volume.

Primary Outcome Measure

To assess the disease control of participants who receive dose and volume-de-escalated radiotherapy to the neck, guided by treatment response through circulating tumor-modified HPV DNA testing [ Time Frame: up to 2 years after radiotherapy ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Miami Cancer InstituteMiamiFlorida33176
Noah Kalman, M.D.
[email protected]
(786) 596-2000
Noah Kalman, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22908
Song W
[email protected]
4342430008
Chris McLaughlin, M.D. (PRINCIPAL_INVESTIGATOR)
Eastern Virginia Medical SchoolNorfolkVirginia23507
Edwin Crandley, M.D.
Bon SecoursRichmondVirginia23114
Chris Chipko, MD
Virginia Commonwealth UniversityRichmondVirginia23284
Shiyu Song, M.D.
[email protected]

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By research site
Miami Cancer Institute· Miami, FLUniversity of Virginia· Charlottesville, VAEastern Virginia Medical School· Norfolk, VABon Secours· Richmond, VAVirginia Commonwealth University· Richmond, VA

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