NCT00003901已完成3 期
A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,310
- 试验地点
- 115
- 主要终点
- Overall Survival in Lymph Nodes Examined Patients
研究概览
简要总结
RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment.
PURPOSE: Phase III trial to study the relationship between early signs of metastases and survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.
详细描述
OBJECTIVES:
- Determine the relationship between three indicators of occult metastases (cytological examination of pleural lavage, immunohistochemistry (IHC) assay of lymph nodes, and IHC assay of rib bone marrow) and survival of patients with resectable non-small cell lung cancer.
- Determine the relationship between these indicators and conventional histology.
- Model survival considering the indicators and other patient attributes that are of prime prognostic significance.
- Determine the relationships between the indicators and the site of first recurrence in these patients.
- Determine the prevalence of the indicators in these patients.
- Determine the relationships between the indicators and disease free survival 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 old.
- •Patient must have ECOG/Zubrod status <
- •Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I, IIa, IIb or IIIa, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer.
- •Patient must have N1 or N2 disease. NOTE: Patient must undergo mediastinoscopy if preoperative studies suggest N3 disease.
- •Patient must have a pathologic diagnosis (pre-operative or intra-operative) of NSCLC prior to registration.
- •Patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary NSCLC. NOTE: The preoperative assessment of resectability should, at a minimum, include a CT scan of the chest and upper abdomen, including the adrenal glands, within 60 days prior to registration.
- •Patient must be medically fit for surgery.
- •Patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection.
- •Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
- •Patient must be available for follow-up.
- •If the patient is a survivor of a prior cancer, all of the following criteria must apply:
- •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 has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest CT scan.
- •Patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years.
- •Patient has received prior chemotherapy or radiotherapy for this cancer.
- •Patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
- •Patient for whom the surgeon plans to perform only a wedge resection for treatment.
结局指标
主要结局
Overall Survival in Lymph Nodes Examined Patients
时间窗: Up to 5 years
Overall survival was defined as the time period between patient registration and death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).
Overall Survival in Bone Marrow Examined Patients
时间窗: Up to 5 years
Overall survival was defined as the time period between patient registration and death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).
次要结局
- Disease-Free Survival in Lymph Nodes Examined Patients(Up to 5 years)
- Disease-Free Survival in Bone Marrow Examined Patients(Up to 5 years)
研究者
研究点 (115)
Loading locations...
相似试验
已完成
不适用
Detection of Early Metastases in Patients With Stage I Non-small Cell Lung CancerLung CancerNCT00003006Alliance for Clinical Trials in Oncology501
已完成
不适用
Blood Levels of Tumor Cells in Predicting Response in Patients Receiving First-Line Chemotherapy for Stage IV Breast CancerBreast CancerNCT00898014Institut Curie216
Unknown
不适用
Diagnostic Imaging of Bone Metastases in Prostate Cancer PatientsProstate Cancer Metastatic to BoneNCT03134261Herlev Hospital300
招募中
不适用
Blood Cell RNA-Based Cancer DetectionNeoplasmsCancerNCT05839834Wuhan Union Hospital, China5,000
已完成
不适用
Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By SurgeryColorectal CancerNCT00898846Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1,111