High Risk Cutaneous Squamous Cell Carcinoma Treated With Mohs Surgery Randomized to Elective Management of the Draining Lymph Nodes vs. Periodic Clinical Nodal Observation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Disease-specific survival
研究概览
简要总结
This study will evaluate if there is a difference in survival between elective treatment of draining lymph nodes vs. clinical nodal observation in patients undergoing Mohs surgery for high risk skin squamous cell carcinoma of the head and neck who have a normal lymph node exam. Each treatment arm is accepted as a current standard of care, and the objective is to compare outcomes between the two arms.
详细描述
This is a prospective, randomized, non-blinded, controlled trial of high risk head and neck cutaneous squamous cell carcinomas which will compare specific outcomes between two treatment arms. Subjects are eligible patients who are sent to Zitelli & Brodland PC for Mohs micrographic surgery of tumors that meet our high risk criteria. These patients with clinically-negative lymph node exams will either enter into the arm of nodal observation or the arm of elective management of the neck, which is currently the standard protocol per the UPMC ENT department. The patients in the observation arm will have evaluation and treatment of their lymph nodes if an abnormality is detected clinically. The primary endpoint is disease-specific survival. Secondary endpoints will include overall and disease-free survival, complications, and quality of life measures for each arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Major criterion and at least one minor criteria
- •Major criterion: > 6 mm depth of invasion
- •Minor criteria (one or more):
- •Greater than 2cm diameter
- •Recurrent (prior Mohs, wide local excision, electrodesiccation and curettage, topical imiquimod or 5 fluorouracil, cryotherapy or photodynamic therapy)
- •High risk location: any portion of cutaneous lip, ear, temple, scalp
- •Immunosuppressed host (organ transplant recipient or chronic lymphocytic leukemia)
- •Perineural invasion (yes/no; nerve involved must be greater than 0.1mm)
- •Direct involvement of subcutaneous tissue (Clark's V), muscle, cartilage,or bone
排除标准
- •Satellite metastases
- •Clinically abnormal lymph node exam
- •Location other than head or neck
- •Exclusively mucosal squamous cell carcinoma
- •Previous head and neck radiation
- •In situ disease, keratoacanthoma subtypes, metatypical or collision tumors
- •Inability of subject to give written informed consent
- •Pregnancy
研究组 & 干预措施
Elective lymph node treatment arm
Patients entering this arm will undergo selective nodal dissection of the draining lymph nodes with subsequent radiation and/or chemotherapy if indicated.
干预措施: elective lymph node dissection (Procedure)
Clinical observation arm
Patients who enter into this arm will undergo regular, periodic clinical nodal observation with subsequent evaluation and treatment if indicated upon discovery of a palpable lymph node.
结局指标
主要结局
Disease-specific survival
时间窗: 5 years
次要结局
- Overall survival(5 years)
- Disease-free survival(5 years)
- Complications(5 years)
- quality of life(5 years)
研究者
John Zitelli
John A Zitelli, MD
University of Pittsburgh