NCT04937283Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 690 (estimated)
- First submitted
- 24 Apr 2021
- Start date
- 1 Oct 2019
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Diseases
- Lung cancer
- NCT number
- NCT04937283
What you commit to
- Study type: Interventional
- Planned participants: 690
- From 1 Oct 2019 to the primary completion date, 30 Dec 2028
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior chemotherapy, radiation therapy or any other therapies were performed; 12 participated in other tumors within three months of relevant clinical subjects;
Other illness
- Patients with other malignant tumors;
Lab values
- 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);
Other
- 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;
- Pregnant, planned pregnancy and lactating female patients (urine HCG\>2500IU/L is diagnosed as early pregnancy);
- 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.
Who the study is looking for
- 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.
Age in the registry: 20 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital of University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Anhui Chest Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Huzhou Central Hospital Coordinator of this site? Confirm its status | Huzhou | China | Recruiting |
| Shandong Public Health Clinical Center Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| The Sixth People's Hospital of Nantong Coordinator of this site? Confirm its status | Nantong | China | Recruiting |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Recruiting |
| Nanyang Central Hospital Coordinator of this site? Confirm its status | Nanyang | China | Recruiting |
| Ningbo No.2 Hospital Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| Ningbo First Hospital Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| Huadong Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Affiliated Hospital of Xuzhou Medical University Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
| Yancheng First People's Hospital Coordinator of this site? Confirm its status | Yancheng | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.