Shortened Course of Radiation Therapy After Trans-oral Robotic Surgery in Patients With HPV-Mediated Oropharyngeal Squamous Cell Carcinoma.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About this trial

The goal of this study is to evaluate if a shorter course of therapy can improve the quality of life in patients receiving radiation therapy after trans-oral robotic surgery.

Eligibility criteria

Qualifiers

Participant aged ≥ 18 years.

Diagnosis of oropharyngeal squamous cell carcinoma.

Eligible to receive transoral robotic surgery.

If status is known, p16 positivity or HPV positivity by in situ hybridization on pathological sampling of lymph node or primary oropharyngeal tumor. If status not known at the time of step-1 registration, otherwise eligible participants may be enrolled and HPV/p16 status must be determined prior to step-2 registration.

Disqualifiers

History of prior mucosal head and neck cancer treated with radiation therapy

Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this study

Participant has smoked cigarettes within 1 month of registration

Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.

Trial design

Treatments tested in this trial

  • Radiation Therapy

Treatment groups

42 Participants
are divided into 2 treatment groups

Sponsors and collaborators