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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

ConditionsLocally Advanced Oral Cavity Squamous Cell CarcinomaLocally Recurrent Oral Cavity Squamous Cell CarcinomaOral Cavity Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this 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. Proton SFRT is a type of external beam radiation treatment that uses streams of protons (tiny particles with a positive charge) to deliver different doses of radiation to different parts of the tumor in a grid like pattern. This type of radiation kills tumor cells but does not damage nearby tissues. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant proton SFRT or SBRT in combination with pembrolizumab may be safe and tolerable and may be an effective approach to shrink the tumor, reduce the extent of surgery and/or the need for further treatment in patients with locally advanced or locoregionally recurrent oral cavity squamous cell cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2

Disqualifiers

Participation in another clinical study with an investigational product during the last 3 months (12 weeks)

Exception: Unless it is an observational (non-interventional) clinical study during the follow-up period of the study

Contraindications to pembrolizumab

Prior radiation therapy to the head and neck

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo tissue biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo PET/MRI

  • Pembrolizumab

    Biological/Vaccine

    Given IV

  • Photon Stereotactic Body Radiation Therapy

    Radiation

    Receive photon SBRT

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT or PET/MRI

  • Spatially-fractionated Radiation Therapy

    Radiation

    Receive proton SFRT

  • Surgical Procedure

    Procedure/Surgery

    Undergo surgical resection

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm A (proton SFRT, pembrolizumab, surgery)Experimental treatment 8 interventions
Group B: Arm B (photon SBRT, pembrolizumab, surgery)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Improvement in major pathologic response rate (MPR)

MPR is defined from pathologic evaluation of the surgically resected tumor, demonstrating less than 10% of residual tumor in the resection sample (≥90% disease reduction). Will be assessed using a Bayesian pick-the-winner randomized phase-II clinical trial design.

Time frame
At the time of surgical resection

Secondary outcomes

1

Pathologic complete response rate

Pathologic complete response rate is defined from pathologic evaluation of the surgically resected tumor, demonstrating no signs of residual disease following immuno-radiation. This will be calculated separately for Arm A and for Arm B.

Time frame
At the time of surgical resection
2

Percent of patients receiving the prescribed therapy

Will be defined as the number of patients who received the prescribed therapy divided by the number of evaluable patients who signed a consent form and began treatment. This will be calculated separately for Arm A and Arm B.

Time frame
Up to 1 year
3

Incidence of Adverse Events (AEs) Prior to Surgery:

Overall AEs, overall toxicities, and by maximum grade per type of AE per patient of the AEs that occur before surgery will be explored and summarized descriptively, mainly through the use of frequency tables. Toxicity is defined as an adverse event that is classified as possibly, probably, or definitely related to study treatment. AEs are graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.

Time frame
From the time of registration until surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: