Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

NCT05838053 | Recruiting

• 1 other identifier: STAR 002
• Study Type: observational
• Target: 446
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Adenocarcinoma

Keywords

frozen sections; lobectomy; segmentectomy; micropapillary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• overall survival rate

  5 year

Study Arms (2)

Lobectomy with systemic lymph node dissection

lobectomy 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.

Procedure: Lobectomy with systemic lymph node dissection

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 after a comprehensive evaluation. As with lobectomy, 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 in the same manner as with lobectomy.

Procedure: Segmentectomy with systemic lymph node dissection

Interventions

Lobectomy with systemic lymph node dissection PROCEDURE

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.

Lobectomy with systemic lymph node dissection

Segmentectomy with systemic lymph node dissection PROCEDURE

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.

Segmentectomy with systemic lymph node dissection

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

clinical stage IA patients with Lung Adenocarcinoma ≤ 2cm as well as micropapillary and solid Subtype positive (\>5%) by frozen sections

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Yangpu, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Central Study Contacts

Long Xu, MD

CONTACT

15801783037; xulong1228@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of thoracic surgery; Principal Investigator

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 1, 2023
• Study Start: August 20, 2019
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

CN (1)