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
20 augustus 2026 bijgewerkt door: Mayo Clinic
Phase II: Randomized Neoadjuvant Treatment of Oral Cavity Cancer With Spatially Fractionated Proton Radiotherapy and Immunotherapy (OSPRI)
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
- Biologisch: Pembrolizumab
- Procedure: Biospecimen-collectie
- Procedure: Magnetische resonantie beeldvorming
- Procedure: Chirurgische ingreep
- Procedure: Computertomografie
- Procedure: Positronemissietomografie
- Procedure: Biopsieprocedure
- Straling: Spatially-fractionated Radiation Therapy
- Straling: Photon Stereotactic Body Radiation Therapy
Studietype
Ingrijpend
Inschrijving (Geschat)
30
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Clinical Trials Referral Office
- Telefoonnummer: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
Studie Locaties
-
-
Minnesota
-
Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic in Rochester
-
Contact:
- Clinical Trials Referral Office
- Telefoonnummer: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
-
Hoofdonderzoeker:
- Daniel K. Ebner, MD, MPH
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion 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
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
- Eligible to receive immunotherapy on multidisciplinary evaluation
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide signed written informed consent in accordance with ethical, regulatory, and institutional requirements
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- Willing to consent to and provide tissue and blood samples for correlative research purposes (not the optional Riskguard and OncoExtra testing)
- PD-L1 combined positive score ≥ 1
Exclusion Criteria:
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
- Previous anticancer therapeutic received ≤ 30 days prior to registration, or adequate washout period on a per-agent basis, or concurrent anti-cancer therapeutic not specified by this protocol
- Uncontrolled pre-existing condition(s), such as infection, congestive heart failure, hypertension, angina, arrhythmia, chronic diarrhea, psychiatric conditions, or others, that in the opinion of the treating investigator limits the ability to provide consent or longitudinal participation in this study
- Inability to place 2 or more SFRT spheres within the tumor target
- Prophylactic placement of feeding tubes is not allowed
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Arm A (proton SFRT, pembrolizumab, surgery)
Patients receive proton SFRT QOD for up to 3 treatment fractions over 1 week.
Starting within 7 days of initiating SFRT, patients receive pembrolizumab IV on day 1 of each cycle.
Cycles repeat every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Within 8 weeks of completing pembrolizumab, patients undergo surgical resection per standard of care.
Patients also undergo blood sample collection, CT, and PET/MRI or PET/CT throughout the study.
Additionally, patients may also undergo tissue biopsy at baseline and/or on study.
|
IV gegeven
Andere namen:
Bloedafname ondergaan
Andere namen:
Onderga PET/MRI
Andere namen:
Onderga chirurgische resectie
Andere namen:
CT of PET/CT ondergaan
Andere namen:
Onderga PET/CT of PET/MRI
Andere namen:
Ondergaan weefselbiopsie
Andere namen:
Receive proton SFRT
Andere namen:
|
|
Experimenteel: Arm B (photon SBRT, pembrolizumab, surgery)
Patients receive photon SBRT QOD for up to 3 treatment fractions over 1 week.
Starting within 7 days of initiating SBRT, patients receive pembrolizumab IV on day 1 of each cycle.
Cycles repeat every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Within 8 weeks of completing pembrolizumab, patients undergo surgical resection per standard of care.
Patients also undergo blood sample collection, CT, and PET/MRI or PET/CT throughout the study.
Additionally, patients may also undergo tissue biopsy at baseline and/or on study.
|
IV gegeven
Andere namen:
Bloedafname ondergaan
Andere namen:
Onderga PET/MRI
Andere namen:
Onderga chirurgische resectie
Andere namen:
CT of PET/CT ondergaan
Andere namen:
Onderga PET/CT of PET/MRI
Andere namen:
Ondergaan weefselbiopsie
Andere namen:
Receive photon SBRT
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Improvement in major pathologic response rate (MPR)
Tijdsspanne: At the time of surgical resection
|
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.
|
At the time of surgical resection
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pathologic complete response rate
Tijdsspanne: At the time of surgical resection
|
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.
|
At the time of surgical resection
|
|
Percent of patients receiving the prescribed therapy
Tijdsspanne: Up to 1 year
|
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.
|
Up to 1 year
|
|
Incidence of Adverse Events (AEs) Prior to Surgery:
Tijdsspanne: From the time of registration until 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.
|
From the time of registration until surgery
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Daniel K. Ebner, MD, MPH, Mayo Clinic in Rochester
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
7 september 2026
Primaire voltooiing (Geschat)
1 april 2030
Studie voltooiing (Geschat)
1 april 2030
Studieregistratiedata
Eerst ingediend
20 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
20 augustus 2026
Eerst geplaatst (Werkelijk)
25 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
25 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
20 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Neoplasmata per histologisch type
- Hoofd- en nekneoplasmata
- Neoplasmata, glandulair en epitheel
- Carcinoom
- Carcinoom, plaveiselcel
- Plaveiselcelcarcinoom van hoofd en hals
- Onderzoekstechnieken
- Klinische laboratoriumtechnieken
- Diagnostische technieken en procedures
- Diagnose
- Cytologische technieken
- Cytodiagnose
- Diagnostische technieken, chirurgisch
- Chemie -technieken, analytisch
- Spectrumanalyse
- Biopsie
- Exemplaarbehandeling
- pembrolizumab
- Magnetische resonantiespectroscopie
- Chirurgische procedures, operatief
Andere studie-ID-nummers
- GMROR2472
- NCI-2026-05918 (Register-ID: CTRP (Clinical Trial Reporting Program))
- 24-011038 (Andere identificatie: Mayo Clinic Institutional Review Board)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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