Actively Recruiting
Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma (REDUCE-30)
Led by Sara Medek · Updated on 2026-05-18
31
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new radiation treatment approach for people with HPV positive oropharyngeal squamous cell carcinoma. This phase II study aims to see if lowering the radiation dose to areas without visible cancer can be as effective as the standard dose while reducing side effects and improving quality of life. Participants will still receive the usual chemotherapy drug cisplatin alongside radiation therapy. The study involves giving radiation at a reduced dose of 30 Gy to the primary tumor and nearby lymph nodes without visible cancer, instead of the usual higher dose range of 46 to 54 Gy. Visible cancer areas will continue to receive the standard radiation dose. Cisplatin chemotherapy will be administered weekly or every three weeks during radiation. Radiation starts with coverage of the primary site and elective nodes at the lower dose, then focuses on the tumor and involved nodes at the full dose. Participants will undergo PET/CT imaging to measure disease and will be monitored for progression-free survival over two years. Researchers will collect safety data on side effects for up to 90 days after treatment and assess quality of life using specific questionnaires at baseline, treatment completion, and every six months for two years. The study lasts about two years per participant, including follow-up and monitoring of outcomes.
CONDITIONS
Brief Title
Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have confirmed squamous cell carcinoma of the oropharynx planned for definitive chemoradiation.
- Cancer must be confirmed p16 positive by immunohistochemical staining.
- Clinical stage must be T1-4N1-3M0 or T3-T4N0M0 according to AJCC version 8.
- Patients must have measurable disease based on PET/CT imaging within 45 days of eligibility confirmation.
- Age 18 years or older.
- ECOG performance status of 0, 1, or 2.
- Eligible for standard cisplatin chemotherapy as determined by the treating doctor.
- Women of childbearing potential and men must agree to use contraception during the study.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Patients with metastatic or recurrent disease.
- Carcinoma of unknown primary site in the neck (T0 stage ineligible even if p16 positive).
- Prior radiotherapy overlapping planned treatment fields.
- Pregnant, nursing, or intending to conceive or father children during the study.
- Active autoimmune or connective tissue disease requiring systemic treatment.
- Receiving other investigational agents currently (prior use may be allowed at investigator discretion).
- Uncontrolled illness or conditions making participation unsafe or unsuitable as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 to 7 weeks of radiation therapy with concurrent weekly or triweekly cisplatin dosing
Participants receive reduced dose radiation therapy to regions without visible cancer, along with standard cisplatin chemotherapy during radiation treatment.
Weekly visits for radiation and chemotherapy administration
Duration - Up to 2 years post-treatment
Participants are monitored for safety, adverse events, and quality of life after treatment completion.
Visits at treatment completion and every 6 months for 2 years
Trial Site Locations
Total: 1 location
1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
U
UCCC Clinical Trials Office
S
Sara Medek, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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