一项针对 HPV 阳性喉癌患者的个性化放射治疗与标准放射治疗进行比较的研究
FMISO PET 选择的良好风险降级辐射与未选择的 HPV 阳性口咽癌的标准护理辐射的 III 期随机双盲试验
The researchers are doing this study to find out if a personalized approach to chemoradiation therapy (which may include a lower dose of radiation) is as effective as the standard chemoradiation therapy in people with HPV-positive throat cancer. Other purposes of this study include looking at the following:
- Whether a lower dose of radiation in combination with standard chemotherapy causes fewer side effects than the standard dose of radiation therapy in combination with standard chemotherapy
- How the study approaches (lower dose of radiation therapy + standard chemotherapy and standard dose of radiation therapy + standard chemotherapy) affect participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Nancy Lee, MD
- 电话号码：212-639-3341
- 邮箱：leen2@mskcc.org
研究联系人备份
- 姓名：Nadeem Riaz, MD
- 电话号码：646-888-3495
学习地点
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Connecticut
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Hartford、Connecticut、美国、06102
- 招聘中
- Hartford Healthcare (Data Collection Only)
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接触：
- Charles Rutter, MD
- 电话号码：860-972-2803
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Florida
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Miami、Florida、美国、33143
- 招聘中
- Baptist Alliance MCI (Data Collection Only)
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接触：
- Noah Kalman, MD
- 电话号码：786-596-2000
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New Jersey
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Basking Ridge、New Jersey、美国、07920
- 招聘中
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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接触：
- Nancy Lee, MD
- 电话号码：212-639-3341
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Middletown、New Jersey、美国、07748
- 招聘中
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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接触：
- Nancy Lee, MD
- 电话号码：212-639-3341
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Montvale、New Jersey、美国、07645
- 招聘中
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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接触：
- Nancy Lee, MD
- 电话号码：212-639-3341
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New York
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Commack、New York、美国、11725
- 招聘中
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
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接触：
- Nancy Lee, MD
- 电话号码：212-639-3341
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Harrison、New York、美国、10604
- 招聘中
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
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接触：
- Nancy Lee, MD
- 电话号码：212-639-3341
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New York、New York、美国、10065
- 招聘中
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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接触：
- Nancy Lee, MD
- 电话号码：212-639-3341
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Uniondale、New York、美国、11553
- 招聘中
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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接触：
- Nancy Lee, MD
- 电话号码：212-639-3341
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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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Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) or squamous cell carcinoma with an unknown primary. Surgical removal of primary site is allowed.
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Patients must test positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ hybridization (RNAscope® 2.5 HD Reagent kit (Advanced Cell Diagnostics, Inc, Hayward, CA). Any CLIA certified testing method can be used.
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Clinical stage Tx-2, N1-2c (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET/CT.
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ECOG Performance Status of 0-1 or KPS >/=70
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Age ≥ 18
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Adequate hematologic function within 30 days prior to registration, defined as follows:
- White Blood Count (WBC) ≥ 2 K/mcL
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3
- Platelets ≥ 100,000 cells/mm^3
- Hemoglobin ≥ 10.0 g/dl
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Adequate renal function within 30 days prior to registration, defined as follows:
o Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male)
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Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
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The patient must provide study-specific informed consent prior to study entry
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Optional section of the protocol: Patients must be able to undergo MRI scans, i.e. not claustrophobic
Exclusion Criteria:
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Patients with prior head and neck radiation therapy where there is >30% overlap with the current head and neck radiation fields. Exceptions can be made if determined by the PI/Co-PI that the patient can proceed with protocol activities
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Patients whose tumors are borderline T4 based on anterior tumor extension to the extrinsic muscles of the tongue
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Patients with simultaneous primary cancers outside of the oropharynx
o Note: Exceptions can be made for patients with simultaneous primaries outside the oropharynx if determined by the PI/Co-PI the patient can proceed with protocol activities
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Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years to be 90% or greater
o Note: Exceptions can be made for patients with prior malignancies outside the oropharynx if determined by the PI/Co-PI the patient can proceed with protocol activities.
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Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
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No particle therapy
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Patients who are deemed non-compliant to all the protocol related activities
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Contraindications to receive either cisplatin or the combination of carboplatin/5-fluorouracil at the prescribed doses.
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Severe, active co-morbidity defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
- Hepatic Insufficiency resulting in clinical jaundice and/or coagulation defects
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Personalized Chemoradiation Therapy
Patient without evidence of hypoxia will receive 30Gy in 2Gy per fraction. Concurrent chemotherapy will be given as per guidelines. After completion of chemotherapy and radiation therapy, a 4 month (+/- 4 weeks) posttreatment standard FDG PET/CT scan will be performed and if there is persistent disease, standard neck dissection will be performed. Further standard of care will be given pending pathologic findings.1. Hypoxia negative: The entire target volume which includes GTV and CTV will receive 30Gy in 2 Gy per fraction over 15 days (PTV30). 2. Hypoxia positive (same as the standard of care): The CTV will receive 50Gy in 2Gy per fraction over 25 days. This is name PTV50 and will receive 50Gy in 2Gy per fraction over 25 days. The GTV will receive an additional boost of 20Gy in 2 Gy per fraction so that the total PTV70 dose is 70Gy. |
Patients will undergo 18F-FMISO scan (only 1 injection) that occurs at week two of radiation treatment, typically day 10 but a window of 8-10 radiation treatment days* after start of radiation is allowed. 30 Gy or 70 Gy of radiation in combination with standard chemotherapy (cisplatin, carboplatin, and 5-FU) 70 Gy of radiation in combination with standard chemotherapy (cisplatin, carboplatin, and 5-FU) EQ-5D-5L (5 questions); 2. MDADI-HN (total of 20 questions); 3. COST-FACIT (total of 12 questions). |
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有源比较器：Standard Chemoradiation Therapy
Patient will receive 70Gy in 2Gy per fraction regardless of hypoxia status. Concurrent chemotherapy will be given as per guidelines. After completion of chemotherapy and radiation therapy, a 4 month (+/- 4 weeks) posttreatment standard FDG PET/CT scan will be performed and if there is persistent disease, standard neck dissection will be performed. Further standard of care will be given pending pathologic findings. |
Patients will undergo 18F-FMISO scan (only 1 injection) that occurs at week two of radiation treatment, typically day 10 but a window of 8-10 radiation treatment days* after start of radiation is allowed. 30 Gy or 70 Gy of radiation in combination with standard chemotherapy (cisplatin, carboplatin, and 5-FU) 70 Gy of radiation in combination with standard chemotherapy (cisplatin, carboplatin, and 5-FU) EQ-5D-5L (5 questions); 2. MDADI-HN (total of 20 questions); 3. COST-FACIT (total of 12 questions). |
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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overall survival
大体时间：2 years
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The measurement of survival will be evaluated as a time from randomization to events endpoint (i.e., death due to any cause) so that censored data are allowed. To assess the overall survival rate, Kaplan-Meier estimates will be calculated and reported. |
2 years
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合作者和调查者
调查人员
- 首席研究员：Nancy Lee, MD、Memorial Sloan Kettering Cancer Center
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
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.