Lymphadenectomy in NSCLC With and Without Adjuvant Therapy

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04419935
• Other study ID #: 3100
• Status: Active, not recruiting
• Start date: May 13, 2020
• Est. completion date: May 1, 2025

Study information

• Verified date: June 2020
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• AGE < 18 years

• Pregnancy

• Psychiatric disease

• Wedge resection

• Distant metastases

Related Conditions & MeSH terms

• Lymph Node Metastases
• Neoplasm Metastasis
• NSCLC

Intervention

Procedure:
• lymphadenectomy
Lymphadenctomy according with ESTS guidelines

Locations

Country	Name	City	State
Italy	Marco Chiappetta	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the prognostic role of the number of resected and metastatic lymph nodes in pathologically node-positive NSCLC patients underwent surgical resection	overall survival will be used to assess the prognostic role of number of resected and metastatic nodes.	5 years