Maximizing Lymph Node Dissection on Fresh and Fixed Lung Cancer Resection Specimens

• ClinicalTrials.gov Identifier: NCT06252129
• Recruitment Status: Not yet recruiting
• First Posted: February 9, 2024
• Last Update Posted: February 9, 2024
• Sponsor: Brigham and Women's Hospital
• Information provided by (Responsible Party): Paula Antonia Ugalde Figueroa, Brigham and Women's Hospital

Study Description

Brief Summary:

Lung cancer patients undergoing upfront surgery, highly benefit from a systematic lymph node dissection in the mediastinum and in the surgical specimens. The latter is performed by the pathologist. Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.

Condition or disease	Intervention/treatment	Phase
Lung Cancer; Lymph Node Metastasis; Pathologic Processes	Other: Subjects undergoing a lung specimen lymph node dissection; Other: Control group	Not Applicable

Detailed Description:

Anatomic lung resection with systematic mediastinal lymph node dissection is the standard of care for patients with clinical stage I or II non-small cell lung cancer (NSCLC). While the best type of resection may sometimes be debated, it is clear that mediastinal, hilar, and lobar lymph nodes (LNs) should be routinely retrieved to achieve a complete lung cancer resection. According to major international guidelines, at least 3 hilar/intrapulmonary stations and 3 mediastinal stations should be assessed during resection. Although there is still a debate over whether the ideal number of LN stations sampled or the total number of LNs removed per station provides a better analysis, radical systematic LN dissection seems to offer the best oncological outcomes. In fact, in patients with tumors ≤4 cm in diameter completely resected, the quality of the mediastinal lymph node dissection and the thoroughness of the examination of the surgical specimen will select candidates for adjuvant treatment and define oncologic prognosis. The consequences of an incorrect lymph node classification can be substantial: while patients with N0 NSCLC have approximately 75% 5-year overall survival (OS), patients with NSCLC classified as N1 have a 5-year OS of 49%, and patients with NSCLC classified as N2 a 5-year OS of 36%. Therefore, the burden of determining the correct prognosis lies on the surgeon to perform a rigorous and thorough oncological resection, and on the pathologist to fully assess enough intrapulmonary LNs. Inaccuracy by either specialist leads to pathologic understage and suboptimal clinical management, which will lead to poor patient outcomes.

Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Maximizing Lymph Node Dissection on Fresh and Fixed Lung Cancer Resection Specimens
• Estimated Study Start Date: February 2024
• Estimated Primary Completion Date: April 2025
• Estimated Study Completion Date: December 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1. Interventional group; subjects who are being consented to this study and undergoing lymph node dissection as outlined in this protocol	Other: Subjects undergoing a lung specimen lymph node dissection; A lobectomy specimen's resection will undergo systematic lymph node dissection either by the patient's treating thoracic surgeon and/or by a member of the pathology team. The protocol for a standardized lymph node dissection consists of a series of blunt peribronchial dissections starting from the hilum to the periphery, with particular attention to points of airway bifurcation where intrapulmonary lymph nodes aggregate. By emphasizing the intrapulmonary lymph node map and a standardized dissection, the team will remove more lymph nodes from the lobectomy specimen, resulting in an accurate N staging.
No Intervention: Concurrent non-interventional group
Retrospective cohort from 2021-2020	Other: Control group; Control group

Outcome Measures

Primary Outcome Measures :

1. Number of lymph nodes sampled [ Time Frame: 2 weeks ]
   To compare the number of stations and lymph nodes sampled when adopting a standardized technique compared to the conventional (prior) technique.
2. Nodal upstage rate [ Time Frame: 2 weeks ]
   Determine the number of cases upstaged to N1 with the intrapulmonary lymph node dissection compared to the conventional technique.

Secondary Outcome Measures :

1. 3y RFS [ Time Frame: 3 years ]
   Three years recurrence-free survival rate of patients undergoing standardize dissection versus conventional technique.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Subjects with a lung nodule or mass who are eligible to undergo a lobectomy.
2. Subject without any metastasis present.
3. Subjects who have peripheral lung nodule location
4. Subjects must be 18 years of age or older.

Exclusion Criteria:

1. Subjects who received preoperative chemotherapy or radiotherapy.
2. Subjects who have a lung nodule located in a central location. Central tumors are defined by those infiltrating the lobar airway.

Contacts and Locations

Contacts

Contact: Paula Ugalde Figueroa, M.D.; (617) 732-7696; pugaldefigueroa@bwh.harvard.edu

Sponsors and Collaborators

Brigham and Women's Hospital

More Information

• Responsible Party: Paula Antonia Ugalde Figueroa, Associate Surgeon, Division of Thoracic Surgery, Principal Investigator., Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT06252129
• Other Study ID Numbers: DFCI IRB protocol #23-576
• First Posted: February 9, 2024
• Last Update Posted: February 9, 2024
• Last Verified: February 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paula Antonia Ugalde Figueroa, Brigham and Women's Hospital:

NSCLC; Lymph node dissection; Lung cancer staging

Additional relevant MeSH terms:

Lung Neoplasms; Lymphatic Metastasis; Pathologic Processes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes