NCT03274414已完成2 期
A Phase II, Single-Arm Trial Assessing Local Control of Near Total Endoscopic Resection Followed by Concurrent Chemotherapy and Proton Radiation in the Treatment of Unresectable Sinonasal Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 5
- 主要终点
- Local Control Assessment of Unresectable Paranasal Sinus and Nasal Cavity Tumors
研究概览
简要总结
This study is being done to test a new treatment plan for large tumors in the sinus or nasal cavity that will include endoscopic surgery plus chemotherapy and proton-beam radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Age greater than or equal to 18 years.
- •Histopathologically confirmed diagnosis of one the following cancer types:
- •Squamous cell carcinoma
- •Esthesioneuroblastoma
- •Adenoid cystic carcinoma
- •Adenocarcinoma
- •Paranasal sinus/nasal cavity malignancy is considered unresectable with negative margins surgery or resection would be considered excessively morbid. This could include lesions with:
- •Carotid involvement
- •Cavernous sinus invasion
- •Brain invasion
- •Orbital apex
- •Intraconal space
- •Pterygoid musculature involvement
- •Invasion of the clivus
- •Resection of at least 80% of the volume of the tumor is feasible. Resectability will be determined by the surgeon and radiologist after discussion among the multidisciplinary team. For patients who have had surgery at an outside institution, the same parameters will be thoroughly screened to ensure the patient met the same inclusion criteria and resection standards.
- •Patients must be a candidate for surgery (as per treating surgeon) and be able to tolerate proton radiation and chemotherapy (as per treating radiation oncologist and medical oncologist).
- •Karnofsky performance statue >/= 70
- •The subject has organ and marrow function and laboratory values rendering safe administration of Cisplatin:
- •The ANC >/= 1000/mm3 without colony stimulating factor support
- •Platelets >/= 100,000/mm3
- •Hemoglobin >/= 9 g/dL
- •Bilirubin </= 1.5 mg/dL the ULM. For subjects with Gilbert's disease, bilirubin </= 3.0 mg/dL
- •Serum albumin >/= 2.8 g/dl
- •Creatinine clearance (CrCl) >/= 60 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used:
- •Male: CrCl (mL/min) = (140 = age) x wt (kg) / (serum creatinine x 72)
- •Female: Multiply above result by 0.85
- •ALT and AST </= 3.0 ULN
- •Serum phosphorus, calcium, magnesium and potassium >/= LLN
- •No evidence of intercurrent infection
- •Negative pregnancy test for women of childbearing potential (<51 years of age) as per institutional policy.
- •Patients with distant metastatic disease may not be included.
- •Patient must be able to read and write in English.
- •Patients who intitially meet the histopathological inclusion criteria but surgical pathology report shows Sinonasal Undifferentiated Carcinoma.
排除标准
- •Tumor is deemed to be resectable with negative margins by conventional surgical standards.
- •Patients not able to receive standard-dose cisplatin based on the judgement of the treating medical oncologist.
- •Patients with chronic kidney disease (GFR <60), uncontrolled hypertension, congestive heart failure, pre-existing bone marrow dysfunction, or cytopenias.
- •° Congestive heart failure (CHF): New York Heart Association (NYHA) Class II-IV at the time of screening
- •Concurrent uncontrolled hypertension defined as sustained blood pressure > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment; If severe hearing impairment is measured or if significant neuropathy is reported at baseline the treating physician will discuss the risks for further permanent hearing loss and neuropathy with the patient.
- •Patients not able to have a MRI (due to pacemaker, claustrophobia, etc.).
- •Inability to return to MSKCC for frequent scheduled hydration sessions post-chemotherapy.
- •Inability to comply with requirements for cisplatin administration anti-emetic regimens post-treatment.
- •Patients not able or unwilling to travel for proton therapy.
研究组 & 干预措施
Unresectable paranasal sinus/nasal cavity malignancy
Experimental
干预措施: Cisplatin (Drug)
Unresectable paranasal sinus/nasal cavity malignancy
Experimental
干预措施: Adjuvant Proton Radiotherapy (Radiation)
Unresectable paranasal sinus/nasal cavity malignancy
Experimental
干预措施: Endoscopic Resection (Procedure)
Unresectable paranasal sinus/nasal cavity malignancy
Experimental
干预措施: cisplatin and etoposide (Drug)
结局指标
主要结局
Local Control Assessment of Unresectable Paranasal Sinus and Nasal Cavity Tumors
时间窗: 1 year
Assessment of local control after near-total endoscopic resection (NTR) followed by concurrent chemotherapy with proton-beam radiation in unresectable tumors (which we define as expected inability to perform negative margin surgery) of the paranasal sinuses and nasal cavity.
次要结局
未报告次要终点
研究者
研究点 (5)
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