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
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
- Процедура: Biospecimen Collection
- Биологический: Pembrolizumab
- Процедура: Computed Tomography
- Процедура: Biopsy Procedure
- Процедура: Surgical Procedure
- Процедура: Magnetic Resonance Imaging
- Процедура: Positron Emission Tomography
- Радиация: Spatially-fractionated Radiation Therapy
- Радиация: Photon Stereotactic Body Radiation Therapy
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
Контакты и местонахождение
Контакты исследования
- Имя: Clinical Trials Referral Office
- Номер телефона: 855-776-0015
- Электронная почта: mayocliniccancerstudies@mayo.edu
Места учебы
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Minnesota
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Rochester, Minnesota, Соединенные Штаты, 55905
- Рекрутинг
- Mayo Clinic in Rochester
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Контакт:
- Clinical Trials Referral Office
- Номер телефона: 855-776-0015
- Электронная почта: mayocliniccancerstudies@mayo.edu
-
Главный следователь:
- Daniel K. Ebner, MD, MPH
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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)
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Age ≥ 18 years old
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
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Eligible to receive immunotherapy on multidisciplinary evaluation
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Ability to complete questionnaire(s) by themselves or with assistance
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Provide signed written informed consent in accordance with ethical, regulatory, and institutional requirements
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Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
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Willing to consent to and provide tissue and blood samples for correlative research purposes (not the optional Riskguard and OncoExtra testing)
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PD-L1 combined positive score ≥ 1
Exclusion Criteria:
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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
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Contraindications to pembrolizumab
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Prior radiation therapy to the head and neck
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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
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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
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Inability to place 2 or more SFRT spheres within the tumor target
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Prophylactic placement of feeding tubes is not allowed
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
Undergo blood sample collection
Другие имена:
Given IV
Другие имена:
Undergo CT or PET/CT
Другие имена:
Undergo tissue biopsy
Другие имена:
Undergo surgical resection
Другие имена:
Undergo PET/MRI
Другие имена:
Undergo PET/CT or PET/MRI
Другие имена:
Receive proton SFRT
Другие имена:
|
|
Экспериментальный: 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. |
Undergo blood sample collection
Другие имена:
Given IV
Другие имена:
Undergo CT or PET/CT
Другие имена:
Undergo tissue biopsy
Другие имена:
Undergo surgical resection
Другие имена:
Undergo PET/MRI
Другие имена:
Undergo PET/CT or PET/MRI
Другие имена:
Receive photon SBRT
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Improvement in major pathologic response rate (MPR)
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pathologic complete response rate
Временное ограничение: 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
Временное ограничение: 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:
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Daniel K. Ebner, MD, MPH, Mayo Clinic in Rochester
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Новообразования по локализации
- Новообразования
- Новообразования по гистологическому типу
- Новообразования головы и шеи
- Новообразования железистые и эпителиальные
- Карцинома
- Карцинома, плоскоклеточный рак
- Плоскоклеточный рак головы и шеи
- Следственные методы
- Клинические лабораторные методы
- Диагностические методы и процедуры
- Диагноз
- Цитологические методы
- Цитодиагностика
- Диагностические методы, хирургический
- Химические методы, аналитические
- Анализ спектра
- Биопсия
- Обработка образца
- Пембролизумаб
- Магнитно -резонансная спектроскопия
- Хирургические процедуры, оперативные
Другие идентификационные номера исследования
- GMROR2472
- NCI-2026-05918 (Идентификатор реестра: CTRP (Clinical Trial Reporting Program))
- 24-011038 (Другой идентификатор: Mayo Clinic Institutional Review Board)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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