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 Negative by Intraoperative Frozen Sections: A Prospective and Multi-center Randomized Controlled Trial Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937283
• Other study ID #: STAR001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 30, 2028

Study information

• Verified date: July 2023
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Hang Su
• Phone: +86 13917810850
• Email: dreamsuhang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the non-inferiority in recurrence-free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype negative 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 weather segmentectomy is appropriate for invasive adenocarcinoma without micropapillary patterns. This prospective and multi-center study was aimed to evaluate the non-inferiority in recurrence free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma (≤ 2 cm) not including micropapillary components.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 690
• Est. completion date: December 30, 2028
• Est. primary completion date: December 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

• Patient aged 20-79 years old, both male or female;
• Tumor size <= 2cm on preoperative CT scan;
• Peripheral solitary nodule or the associated lesion is MIA or less invasive lesion;
• Preoperative CT indicated that the nodules were non-pure glass nodules (consolidation to tumor ratio >= 0.25);
• Intraoperative frozen section confirmed invasive lung adenocarcinoma with micropapillary and solid subtype negative (<= 5%);
• Intraoperative frozen section indicated the resection margins was free of tumor cells;
• Lung function could withstand both lung segmentectomy and lobectomy (FEV1 > 1.5L or FEV1% >= 60%);
• Eastern Cooperative Oncology Group, 0 to 2;
• Volunteer to participate the trial and sign the informed consent, able to comply with the follow-up plan and other program requirements.

Exclusion Criteria:

• Radiological pure ground glass nodules (consolidation to tumor ratio < 0.25);
• The nodule is close to the lung hilus and is unable to perform segmentectomy;
• Intraoperative frozen section confirmed with micropapillary and solid subtype positive (> 5%);
• Intraoperative frozen section confirmed adenocarcinoma in situ and minimally invasive adenocarcinoma;
• Preoperative imaging examination or EBUS indicated lymph node positive metastasis;
• Preoperative imaging examination revealed distant metastasis;
• Patients with severe damage to heart, liver and kidney function (grade 3 ~ 4, ALT and/or AST over 3 times the normal upper limit, Cr over the normal upper limit);
• Patients with other malignant tumors;
• Pregnant, planned pregnancy and lactating female patients (urine HCG>2500IU/L is diagnosed as early pregnancy);
• Prior chemotherapy, radiation therapy or any other therapies were performed; 12 participated in other tumors within three months of relevant clinical subjects;
• Those who have participated in other tumor-related clinical trials within three months;
• Those are not suitable for participating in trials according to investigator's assessment.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma

Intervention

Procedure:
• 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.
• Lobectomy with hilar and mediastinal 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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Anhui Chest Hospital	Hefei	Anhui
China	The First Affiliated Hospital of University of Science and Technology of China	Hefei	Anhui
China	Huzhou Central Hospital	Huzhou	Zhejiang
China	Shandong Public Health Clinical Center	Jinan	Shandong
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	The Sixth People's Hospital of Nantong	Nantong	Jiangsu
China	Nanyang Central Hospital	Nanyang	Henan
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Ningbo No.2 Hospital	Ningbo	Zhejiang
China	Huadong Hospital	Shanghai	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Yancheng First People's Hospital	Yancheng	Jiangsu

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	Overall survival (OS) was defined as the time from surgery until death from any cause	5 year
Secondary	Post-operative respiratory function	The post-operative respiratory function will be evaluated by FEV1% and FVC.	6 months
Secondary	Operation time	The surgery time in both groups.	24 hours
Secondary	Blood loss	Intraoperative blood loss in total.	24 hours
Secondary	Incidence of operative complications	Any intraoperative complications related to the surgery.	1 month