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临床试验/NCT02555592
NCT02555592Unknown不适用

Treatment Strategy of Surgical Resection With Sequential Adjuvant Chemotherapy and Radiotherapy for Patients With Stage IIIA Non-small Cell Lung Cancer and N2 Disease Only in the Subaortic or Paraaortic Level, or Both

Pusan National University Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
1
主要终点
Three-year disease free survival

研究概览

简要总结

The purpose of this study is to identify the treatment outcomes of surgical resection with sequential adjuvant chemotherapy and radiotherapy in patients with stage IIIA non-small cell lung cancer and N2 disease at only the sub- or para-aortic level.

详细描述

Stage IIIA non-small cell lung cancer (NSCLC) is a very heterogeneous disease and current treatment guidelines recommend concurrent chemoradiation therapy or combined neoadjuvant chemotherapy, surgical resection, and sequential adjuvant therapy. When incidental N2 disease is found despite thorough preoperative staging, adjuvant platinum-based chemotherapy with or without adjuvant radiotherapy is recommended.

Although guidelines suggest preoperative mediastinal staging with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), this method does not allow approach of the sub- or para-aortic lymph nodes. Therefore, patients with suspected stage IIIA NSCLC and N2 disease only at the sub- or para-aortic level should undergo several processes if combined neoadjuvant chemotherapy and surgical resection is planned. First, video-assisted thoracoscopic surgery (VATS) should be performed to verify whether the sub- or para-aortic lymph nodes are involved. If a frozen-section biopsy reveals no malignant tumor involvement in the sub- and para-aortic lymph nodes, the affected lung can be resected. If there is sub- or para-aortic lymph node involvement, further neoadjuvant chemotherapy is required before surgical resection and adjuvant therapy.

Studies have shown that stage IIIA NSCLC with only sub- or para-aortic lymph node involvement has better outcomes than other stage IIIA NSCLC. Moreover, the five-year survival of patients with stage IIIA NSCLC with only sub- or para-aortic lymph node involvement is similar to that with stage II NSCLC. However, those studies were retrospective with relatively small sample sizes. Therefore, we evaluated the outcomes of combined surgical resection with adjuvant chemotherapy and radiotherapy in patients with stage IIIA NSCLC and N2 disease at only the sub- or para-aortic level.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients with stage IIIA non-small cell lung cancer and suspicious of N2 disease only in the subaortic or paraaortic level, or both on chest CT or PET scan

排除标准

  • Patients whose subaortic or paraaortic lymph nodes were revealed as negative by mediastinal lymph node dissection
  • Patients whose mediastinal lymph nodes other than subaortic or paraaortic level were confirmed as malignant node by mediastinal lymph node dissection

结局指标

主要结局

Three-year disease free survival

时间窗: Three year

次要结局

  • Three-year survival rate(Three year)
  • Five-year survival rate(Five year)
  • Recurrence rate(Five year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jung Seop Eom

Clinical assistant professor

Pusan National University Hospital

研究点 (1)

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