Lymphadenectomy in NSCLC With and Without Adjuvant Therapy

June 3, 2020 updated by: Chiappetta marco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Marco Chiappetta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients affected by Non-Small Cell Lung Cancer underwent surgical treatment with anatomical resection + lymphadenectomy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2020

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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