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RECRUITING

NCT04937283

Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

690

Start Date

2019-10-01

Completion Date

2028-12-30

Last Updated

2024-06-17

Healthy Volunteers

Conditions

Lung Adenocarcinoma

Interventions

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.

PROCEDURE

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.

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.

Locations (14)

Anhui Chest Hospital

Hefei, Anhui, China

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Nanyang Central Hospital

Nanyang, Henan, China

The Sixth People's Hospital of Nantong

Nantong, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Yancheng First People's Hospital

Yancheng, Jiangsu, China

Shandong Public Health Clinical Center

Jinan, Shandong, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Huadong Hospital

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Huzhou Central Hospital

Huzhou, Zhejiang, China

Ningbo First Hospital

Ningbo, Zhejiang, China

Ningbo No.2 Hospital