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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06252129
• Other study ID #: DFCI IRB protocol #23-576
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: December 2027

Study information

• Verified date: February 2024
• Source: Brigham and Women's Hospital
• Contact: Paula Ugalde Figueroa, M.D.
• Phone: (617) 732-7696
• Email: pugaldefigueroa[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 2027
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Lymph Node Metastasis
• Lymphatic Metastasis
• Pathologic Processes

Intervention

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.
• Control group
Control group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of lymph nodes sampled	To compare the number of stations and lymph nodes sampled when adopting a standardized technique compared to the conventional (prior) technique.	2 weeks
Primary	Nodal upstage rate	Determine the number of cases upstaged to N1 with the intrapulmonary lymph node dissection compared to the conventional technique.	2 weeks
Secondary	3y RFS	Three years recurrence-free survival rate of patients undergoing standardize dissection versus conventional technique.	3 years