Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Sara Medek
Study ID
NCT07497607
Phase
PHASE2
Status
Recruiting
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Conditions

  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Cisplatin — DRUG
    Subjects will continue to receive standard systemic therapy of cisplatin during radiation therapy. Weekly SOC Cisplatin at a dose of 40mg/m2 or every 3-week dosing of 100mg/m2 will be administered per institutional guidelines during radiation therapy. The first cisplatin infusion should be initiated during the window from 24 hours before, to 48 hours after the first scheduled radiation treatment. Skipped cisplatin infusions should not be made up, and the last cisplatin infusion should be no later than 7 days after the last fraction of radiation.
  • Radiotherapy — RADIATION
    Radiotherapy will involve a sequential boost approach. Treatment will begin with coverage of the primary site and elective nodal regions to 30 Gy, after which treatment volumes will be reduced to primary site and involved nodes only with PTV margin to 70 Gy.

Study Details

This is a single-arm, phase II study that is designed to investigate nodal and primary tumor CTV dose de-escalation (30 Gy) in HPV positive oropharyngeal cancer.

Key Dates

Start date
May 13, 2026
Status verified
Mar 2026
Primary completion
May 13, 2031
Completion
May 13, 2036

Study Design

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

Arms

  • Experimental: Reduced Elective Nodal and CTV Dose
    Reduction in primary tumor and nodal CTV dose to 30 Gy.

Primary Outcome Measure

Change in dose and volume to all clinical target volumes (CTV) via Progression-Free Survival (PFS) [ Time Frame: 2 years post treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Cincinnati Medical CenterCincinnatiOhio45219
Sara Medek, MD

Find similar trials in Cincinnati, OH

By research site
University of Cincinnati Medical Center· Cincinnati, OH

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