Lowering nodal and primary tumor radiation dose in HPV-positive oropharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm phase II trial explores de-escalating radiation to nodal areas and surrounding tissues to 30 Gy while maintaining the standard dose to visible cancer in patients with HPV-positive OPSCC. All participants will continue standard cisplatin chemotherapy during radiotherapy. The goal is to see if lower doses to areas at risk of microscopic disease are still effective and may reduce treatment-related toxicity and improve quality of life. Eligible patients have confirmed HPV-positive OPSCC, measurable disease, and are planned for definitive chemoradiation. The study is conducted at the University of Cincinnati Medical Center under the leadership of Sara Medek.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed history of squamous cell carcinoma of the oropharynx (OPSCC) planned for definitive chemoradiation.
2. Squamous cell carcinoma of the oropharynx (OPSCC) must be confirmed to be p16 positive based on immunohistochemical staining.
3. OPSCC must be clinical stage T1-4N1-3M0 or T3-T4N0M0 as per AJCC volume 8.
4. Patients must have measurable disease based on PET/CT imaging completed within 45 days +/- 1 week from date of eligibility confirmation.
5. Age ≥18 years.
6. ECOG performance status ≤2.
7. Patients must be deemed eligible for planned SOC cisplatin per treating investigators and/or treating medical oncologist.
8. 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.
9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* 1\. Patients with metastatic or recurrent disease.

  2\. Carcinoma of the neck of unknown primary site origin (T0 is ineligible even if p16 is positive).

  3\. Prior radiotherapy resulting in overlap of radiation therapy fields.

  4\. Patients who are pregnant, nursing or intended to conceive or father children during the course of the study.

  5\. Patients with active autoimmune or connective tissue disease that require systemic treatment in the opinion of the Investigator.

  6\. 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.

  7\. 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's running

• University of Cincinnati Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: UCCC Clinical Trials Office
• Email: cancer@uchealth.com
• Phone: 513-584-7698

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sacituzumab govitecan plus cetuximab for recurrent or metastatic head and neck squamous cell cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.