Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

Lung Adenocarcinoma Clinical Trial

Official title:

Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm With Micropapillary and Solid Subtype Positive by Frozen Section: A Prospective, Observational, Multicenter Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838053
• Other study ID #: STAR 002
• Status: Recruiting
• Start date: August 20, 2019
• Est. completion date: April 30, 2028

Study information

• Verified date: July 2023
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Long Xu, MD
• Phone: 15801783037
• Email: xulong1228[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the superiority in recurrence-free survival of lobectomy compared with segmentectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype positive by intraoperative frozen sections.

Description:

At present, the technology of intraoperative frozen section has gradually matured, which can diagnose the benign and malignant tumors and guide the resection strategy for peripheral small-sized lung adenocarcinoma. Travis et al. reported high specificity of intraoperative frozen section in the identification of micropapillary components, confirming that intraoperative frozen section may guide the selection of surgical procedures. However, there is still little evidence whether segmentectomy is appropriate for invasive adenocarcinoma without micropapillary patterns. This prospective and multi-center study was aimed to evaluate the superiority in recurrence free survival and overall survival of lobectomy compared with segmentectomy in patients with lung adenocarcinoma (≤ 2 cm) containing positive micropapillary components.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 446
• Est. completion date: April 30, 2028
• Est. primary completion date: April 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

• Tumor size = 2 cm;
• Solitary tumor and located in the outer third of the lung field;
• Preoperative CT indicated that the nodules were single nodules or Concomitant nodules was less than minimal invasive adenocarcinoma;
• Intraoperative frozen section confirmed invasive lung adenocarcinoma and with micropapillary and solid patterns positive (>5%);
• Confirmation of R0 status by intraoperative frozen section analysis;
• Pulmonary function could withstand both segmentectomy and lobectomy (FEV1 > 1.5 L or FEV1% = 60%);
• Sufficient organ function;
• Performance status of 0,1 or 2;
• Written informed consent.

Exclusion Criteria:

• The tumor is close to the hilum, which cannot perform segmentectomy ;
• Patients suspected of lymph node positive by preoperative examination, including CT scans and mediastinal lymph node biopsy;
• Evidence revealed locally advanced or metastatic disease;
• Intraoperative exploration revealed accidental pleural dissemination.
• Patients with severe damage to heart, liver and kidney function (grade 3 ~ 4, Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) over 3 times the normal upper limit, Cr over the normal upper limit).
• Patients concomitant with other malignant tumors;
• Patients had prior chemotherapy, radiotherapy or molecular targeted therapy for this malignancy.
• History of severe heart disease, heart failure, myocardial infarction within the past 6 months.
• The patients who were not suitable for inclusion by researchers' evaluation.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma

Intervention

Procedure:
• Lobectomy with systemic lymph node dissection
Lobectomy with hilar and mediastinal lymph node dissection is performed. Segmentectomy with hilar and mediastinal lymph node dissection is performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.
• Segmentectomy with systemic lymph node dissection
Segmentectomy with hilar and mediastinal lymph node dissection is performed. If the tumor located at inter-segment plane and without sufficient resection margin distance, a combined segmentectomy will be performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Yangpu	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence-free survival rate	Recurrence-free survival (RFS) was defined as the time from surgery until recurrence or death from any cause	5 year
Secondary	overall survival rate	Overall survival (OS) was defined as the time from surgery until death from any cause	5 year