跳至主要内容
临床试验/NCT04419935
NCT04419935进行中(未招募)不适用

Prognostic Impact of the Kind of Lymphadenectomy and Lymph Node Characteristics on Node-positive Patients Underwent Anatomical Lung Resection With or Without Adjuvant Therapy for Non-Small Cell Lung Cancer

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
250
试验地点
1
主要终点
To evaluate the prognostic role of the number of resected and metastatic lymph nodes in pathologically node-positive NSCLC patients underwent surgical resection

研究概览

简要总结

Adjuvant therapy in patients affected by NSCLC is indicated in surgically treated cases of N2 disease, while the actual guidelines reported the possibility of a case-by-case decision in case of N1 involvement.

On the other hand, the actual categorization of patients based on the hilar or mediastinal involvement (N1 or N2) risks to be too ineffective and straightforward for prognosis prediction and an indication of adjuvant treatments. This issue was underlined in the 8th TNM proposal for the N sub-classification, with a final proposal of different subgroups based on the number of involved stations. However, the IASLC committee noted that this proposal presented some limits due overlapping or not statistical significance among some survival curves, so the proposal was not adopted in the staging system. Moreover, the committee stated that the lack of information regarding some data such as the number of the resected or the metastatic nodes might affect the results and limited other proposals.

The objectives of this study are:

  • To evaluate the prognostic role of the kind of lymphadenectomy, the number of the resected and/or metastatic lymph nodes in surgically treated N positive patients in terms of survival.
  • To evaluate the indication and the role of adjuvant treatments in these patients.
  • To identify patients with increased risk of early recurrence or poor survival based on the lymph node involvement characteristics In particular, data will be collect in a prospective database including clinical and pathological data, kind of lymphadenectomy, number of resected nodes, number of metastatic nodes, kind and schedule of adjuvant therapy and follow-up status

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

  • Informed consent
  • Age >18 years
  • Non-Small Cell Lung Cancer Histology
  • Anatomical lung resection (segmentectomy, lobectomy or bilobectomy, pneumonectomy)
  • Pre-operative CT and PET evaluation
  • Preoperative and postoperative tumour board discussion
  • Intraoperative lymph node assessment (minimum 3 mediastinal stations harvested)
  • Lymph node metastases

排除标准

  • AGE < 18 years
  • Pregnancy
  • Psychiatric disease
  • Wedge resection
  • Distant metastases

结局指标

主要结局

To evaluate the prognostic role of the number of resected and metastatic lymph nodes in pathologically node-positive NSCLC patients underwent surgical resection

时间窗: 5 years

overall survival will be used to assess the prognostic role of number of resected and metastatic nodes.

次要结局

未报告次要终点

研究者

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

Chiappetta marco

Medical Doctor - Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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