NCT00042926已完成不适用
A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 主要终点
- Proportion of non-SLN(s) negative patients
研究概览
简要总结
RATIONALE: Diagnostic procedures to detect cancer cells in sentinel lymph nodes may help plan effective cancer treatment.
PURPOSE: Diagnostic trial to study the effectiveness of lymph node mapping and sentinel lymph node lymphadenectomy in patients who are undergoing surgery to remove early-stage cancer of the mouth.
详细描述
OBJECTIVES:
- Determine whether a negative hematoxylin and eosin finding from the lymphatic mapping and sentinel node lymphadenectomy procedure accurately predicts the negativity of the other cervical lymph nodes in patients with stage I or II squamous cell carcinoma of the oral cavity.
- Determine the extent and pattern of disease spread in the nodal bed in these patients.
- Obtain data on the use of immunohistochemistry to assess nodes in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patient must be > 18 years of age.
- •Patient must have an ECOG/Zubrod performance status of <
- •Patient must have a histologically confirmed primary T1 or T2 invasive OCSCCA that is > 6mm and < 4 cm in size. The primary tumor must be amenable to curative resection and must be diagnosed within 42 days prior to surgery.
- •Patient must be clinically stage N0 confirmed with a negative imaging study employing contrastenhanced CT scan (or MRI with gadolinium in patients with iodine allergy). Lymph nodes will be considered positive if:
- •Greater than 1.5 cm in size for levels I and II.
- •Greater than 1 cm in size for levels III, IV, V and VI.
- •If any lymph node exhibits central necrosis, irregular enhancement of a poorly defined or irregular capsular border.
- •Groups of three or more asymmetrically located LNs, with a minimal axial diameter of 8 mm or more, in the suspected tumor drainage area are present.
- •NOTE: All CT scans must be read by a neuroradiologist.
- •Patient must be medically fit for neck dissection.
- •Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration or any study-related procedures.
- •Female patient of childbearing potential must have negative serum pregnancy test within 30 daysprior to registration.
- •If the patient is a survivor of a prior cancer, ALL of the following criteria are met:
- •Patient has undergone potentially curative therapy for all prior malignancies,
- •No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone),
- •Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
排除标准
- •Patient received prior treatment to the cervical lymph nodes, including surgery or radiation therapy.
- •Patient experienced prior extensive trauma to the anterior cervical region of the neck.
- •Patient has lesions that cross the vermilion border involving lip skin.
- •Patient has had previous tumor resection involving the neck.
- •Patient has had injections of radioactive material for previous scans within 48 hours of the radiolymphoscintigraphy.
结局指标
主要结局
Proportion of non-SLN(s) negative patients
时间窗: Up to 30 days
次要结局
未报告次要终点
研究者
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