Major Radiation Dose De-Escalation Concurrent With Chemotherapy for Human Papilloma Virus Associated Oropharyngeal Carcinoma

Memorial Sloan Kettering Cancer Center8 个研究点分布在 1 个国家目标入组 121 人开始时间: 2022年8月4日最近更新: 2026年3月9日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方: Memorial Sloan Kettering Cancer Center
入组人数: 121
试验地点: 8
主要终点: Number of participants with any locoregional recurrences

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to find out if lower doses of radiation may help reduce the side effects of radiation therapy in combination with standard-of-care chemotherapy in people with HPV-positive throat cancer. The chemotherapy drugs used in this study include cisplatin, carboplatin, and 5-fluorouracil (5- FU), paclitaxel and abraxane- (Albumin-bound Paclitaxel).

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) from biopsy, surgical resection or excisional biopsy regardless of margin status.
•Squamous cell carcinoma of the neck of unknown primary is allowed with excision biopsy of a lymph node (or core biopsy) or consent from the PI or co-PI
•Patient must have excisional biopsy or core biopsy done in order to be on protocol
•Subjects must have clinically or radiographically evident measurable gross disease at either the primary tumor site or nodal stations.
•Oropharyngeal Carcinoma (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET/CT.
•CT or MRI of the neck with and without contrast Note: A CT scan of neck and/or a PET/CT performed for the purposes of radiation planning may serve as planning tools.
•ECOG Performance Status of 0-2 or KPS ≥ 50
•Age ≥ 18 Patients over 70yrs will be able to enroll in Cohort B only).
•Adequate hematologic function within 30 days prior to registration, defined as follows:
•White Blood Count (WBC) ≥ 2 K/mcL
•Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
•Platelets ≥ 100,000 cells/mm3
•Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable
•Adequate renal function within 30 days prior to registration, defined as follows:
•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)
•Note: Patients who cannot tolerate cisplatin or carboplatin/5FU based on clinical judgment will receive carboplatin and paclitaxel Paclitaxel can be substituted with Abraxane (Albumin-bound Paclitaxel).
•Adequate hepatic function within 30 days prior to registration, defined as follows:
•Bilirubin < 2 mg/dl
•AST or ALT < 3 x the upper limit of normal
•Note: Exceptions can be made with PI and/or Co-Pi approval for patients to enroll on trial with a higher Bilirubin level such as Gilbert's Syndrome.
•Note: Patients who cannot tolerate cisplatin or carboplatin/5FU based on clinical judgment will receive carboplatin and paclitaxel. Paclitaxel can be substituted with Abraxane (Albumin-bound Paclitaxel).
•Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
•The subject must provide study-specific informed consent prior to study entry
•Subject able to undergo MRI scans except for major medical contraindications like presence of a pacemaker or approved by the PI or the CO-PI that the subject does not need to undergo MRI scans

排除标准

•Subjects with prior head and neck radiation therapy
•Subjects with simultaneous primary cancers outside of the oropharynx
•a. 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.
•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
•Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
•Severe, active co-morbidity defined as follows: (exceptions can be made if approved by the PI and/or co-PI)
•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