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

Recruiting now · Phase 2

Conditions studied: Oropharyngeal Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma

In brief

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 facts

Study ID

NCT07497607

Run by

Sara Medek

People needed

31

Starts

2026-05-13

Expected to finish

2036-05-13

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically or cytologically confirmed history of squamous cell carcinoma of the oropharynx (OPSCC) planned for definitive chemoradiation.
• Squamous cell carcinoma of the oropharynx (OPSCC) must be confirmed to be p16 positive based on immunohistochemical staining.
• OPSCC must be clinical stage T1-4N1-3M0 or T3-T4N0M0 as per AJCC volume 8.
• Patients must have measurable disease based on PET/CT imaging completed within 45 days +/- 1 week from date of eligibility confirmation.
• Age ≥18 years.
• ECOG performance status ≤2.
• Patients must be deemed eligible for planned SOC cisplatin per treating investigators and/or treating medical oncologist.
• Women of child-bearing potential and men must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• 1. Patients with metastatic or recurrent disease.
• Carcinoma of the neck of unknown primary site origin (T0 is ineligible even if p16 is positive).
• Prior radiotherapy resulting in overlap of radiation therapy fields.
• Patients who are pregnant, nursing or intended to conceive or father children during the course of the study.
• Patients with active autoimmune or connective tissue disease that require systemic treatment in the opinion of the Investigator.
• Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the Investigator.
• Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous or not preferable, in the opinion of the Investigator.

Where it is running

• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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