Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05268614
Phase
PHASE2
Status
Recruiting
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Conditions

  • Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Radiation therapy — RADIATION
    Participants will receive either 70 gray (Gy), 60 Gy, or 50 Gy of radiation based on the following criteria: 70 Gy: Pretreatment level of plasma circulating free HPV DNA (cfHPV DNA) ≤ 3 copies/mL 60 Gy: Tumor tissue positive for HPV subtype other than 16 OR Pretreatment level of cfHPV DNA 4-99 copies/mL OR Pretreatment level of cfHPV DNA ≥ 100 copies/mL AND \<95% decrease in the level cfHPV DNA by the end of week 4 of radiation therapy 50 Gy: Tumor tissue positive for HPV subtype 16, pretreatment level of cfHPV DNA ≥ 100 copies/mL, AND ≥ 95% decrease in the level cfHPV DNA by the end of week 4 of radiation therapy
  • Cisplatin — DRUG
    All participants will receive 40 mg/m2 of cisplatin intravenously over 60 minutes weekly during radiation therapy. If cisplatin is not recommended by the treating medical oncologist or is not tolerated, it is permissible to switch to an alternative chemotherapy regimen per institutional practice, but chemotherapy should not be discontinued unless mandated by the patient's condition.

Study Details

This study builds on the results of several prior studies that we have been involved with to test the hypothesis that Risk-Adapted De-Intensification of Radiation Therapy and chemotherapy based on HPV subtype, plasma circulating free HPV DNA (cfHPV DNA) level, and cfHPV DNA clearance rate produces Local-Regional Control rates that are similar to what has been achieved with more aggressive therapy in patients with Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma (OPSCC).

Key Dates

Start date
May 16, 2022
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2032

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemo-radiotherapy
    Participants will receive chemo-radiotherapy.

Primary Outcome Measure

Local-Regional Control Rate [ Time Frame: 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Lydia Napier
[email protected]
352-273-8139
UF Health Proton Therapy InstituteJacksonvilleFlorida32206
Jonathan Gaskins
[email protected]
904-588-1512
Roi Dagan, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Madelyn Langley
[email protected]
843-792-0198
Bhishamjit Chera, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FLUF Health Proton Therapy Institute· Jacksonville, FLMedical University of South Carolina· Charleston, SC

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