Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial

This phase II trial compares the effect of adding proton spatially fractionated radiotherapy (SFRT) or photon stereotactic body radiotherapy (SBRT) to standard immunotherapy pembrolizumab before surgery (neoadjuvant) in treating patients with oral cavity squamous cell cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has come back where it first started (primary site) or near it (locoregionally recurrent) and have not had (naive) prior radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Pro

Trial Details

NCT ID

NCT07783581

Phase

PHASE2

Sponsor

Mayo Clinic

Status

RECRUITING

Cancer Type

Head and Neck Cancer

Interventions

Biopsy Procedure
Biospecimen Collection
Computed Tomography
Magnetic Resonance Imaging
Pembrolizumab
Photon Stereotactic Body Radiation Therapy

Locations (sample)

Rochester, Minnesota, United States|44.02163,-92.4699

Key Eligibility Criteria

Patients with histologically confirmed human papillomavirus (HPV)/p16-unrelated squamous cell carcinoma of the oral cavity and:
Either locally advanced (T3-T4) non-metastatic disease, or
Radiation-naïve locoregionally recurrent disease (prior radiation to a site outside of the treatment fields is permitted)
Age ≥ 18 years old

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Head and Neck Cancer Trials on Trialify →