Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm
Recruiting · NCT04937283 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
View the official record on ClinicalTrials.gov →Interventions studied
LobectomySegmentectomy
What this trial is about
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.
Who can take part
Age range
20 Years to 79 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
14 locations listed.
- 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 - Ningbo, Zhejiang, China