Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm
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
1 other identifier
interventional
690
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 24, 2021
CompletedFirst Posted
Study publicly available on registry
June 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
April 13, 2026
April 1, 2026
9.3 years
April 24, 2021
April 6, 2026
Conditions
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 (5)
overall survival
5 year
Post-operative respiratory function
6 months
Operation time
24 hours
Blood loss
24 hours
Perioperative morbidity or mortality
1 month
Study Arms (2)
Segmentectomy
EXPERIMENTALSegmentectomy 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. When lymph node metastasis is present or resection margin is not cancer-free, the surgical procedure must be converted to a lobectomy.
Lobectomy
ACTIVE COMPARATORlobectomy 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 intraoperatively. 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 216002, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001, 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, 200433, China
Huadong Hospital
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chang Chen, MD, PhD
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- no masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Thoracic Surgery, Shanghai Pulmonary Hospital
Study Record Dates
First Submitted
April 24, 2021
First Posted
June 24, 2021
Study Start
October 1, 2019
Primary Completion (Estimated)
December 30, 2028
Study Completion (Estimated)
December 30, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share