Comparing segmentectomy and lobectomy for small lung adenocarcinomas

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

This study tests if a smaller surgery called segmentectomy is just as good as a larger surgery called lobectomy for people with small lung tumors to see which one helps them live longer and stay cancer-free.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 690 (estimated)
• Ages: 20 Years to 79 Years
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 14 sites (Hefei, Anhui and 13 other locations)
• Trial ID: NCT04937283 on ClinicalTrials.gov

What this trial studies

This study evaluates whether segmentectomy is as effective as lobectomy in preventing recurrence and improving overall survival in patients with lung adenocarcinoma tumors that are 2 cm or smaller and lack micropapillary components. It utilizes intraoperative frozen section technology to guide surgical decisions based on tumor characteristics. The trial is prospective and multi-center, involving several hospitals in China, and aims to provide evidence on the appropriateness of segmentectomy for specific lung adenocarcinoma cases.

Who should consider this trial

Good fit: Ideal candidates are patients aged 20-79 with a solitary lung nodule ≤ 2 cm that has been confirmed as invasive lung adenocarcinoma without micropapillary components.

Not a fit: Patients with pure ground glass nodules or those whose tumors are too close to the lung hilus to allow for segmentectomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive surgical option for patients with small lung adenocarcinomas, potentially leading to better recovery and quality of life.

How similar studies have performed: While there is limited evidence on segmentectomy for this specific patient group, previous studies have shown promising results for similar surgical approaches in lung cancer treatment.

Eligibility criteria

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 this trial is running

Hefei, Anhui and 13 other locations

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

Study contacts

• Principal investigator: Chang Chen, MD, PhD — Shanghai Pulmonary Hospital, School of Medicine, Tongji University
• Study coordinator: Hang Su

Conditions Lung Adenocarcinoma