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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Clinical Trials Referral Office
- 电话号码：855-776-0015
- 邮箱：mayocliniccancerstudies@mayo.edu
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- 招聘中
- Mayo Clinic in Rochester
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接触：
- Clinical Trials Referral Office
- 电话号码：855-776-0015
- 邮箱：mayocliniccancerstudies@mayo.edu
-
首席研究员：
- Daniel K. Ebner, MD, MPH
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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
其他名称：
Given IV
其他名称：
Undergo CT or PET/CT
其他名称：
Undergo tissue biopsy
其他名称：
Undergo surgical resection
其他名称：
Undergo PET/MRI
其他名称：
Undergo PET/CT or PET/MRI
其他名称：
Receive proton SFRT
其他名称：
|
|
实验性的：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
其他名称：
Given IV
其他名称：
Undergo CT or PET/CT
其他名称：
Undergo tissue biopsy
其他名称：
Undergo surgical resection
其他名称：
Undergo PET/MRI
其他名称：
Undergo PET/CT or PET/MRI
其他名称：
Receive photon SBRT
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement in major pathologic response rate (MPR)
大体时间：At the time of surgical resection
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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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pathologic complete response rate
大体时间：At the time of surgical resection
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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
大体时间：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
|
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Incidence of Adverse Events (AEs) Prior to Surgery:
大体时间：From the time of registration until surgery
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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
|
合作者和调查者
赞助
调查人员
- 首席研究员：Daniel K. Ebner, MD, MPH、Mayo Clinic in Rochester
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GMROR2472
- NCI-2026-05918 (注册表标识符：CTRP (Clinical Trial Reporting Program))
- 24-011038 (其他标识符：Mayo Clinic Institutional Review Board)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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