Clinical trial Recruiting at 14 sites Interventional Ages 20 to 79

Comparing segmentectomy and lobectomy for small lung adenocarcinomas

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

Run by Shanghai Pulmonary Hospital, Shanghai, China · NCT04937283 · Data updated 2026-11-12

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

Study typeInterventional
Ages20 Years to 79 Years
SexAll
Enrollment690 (estimated)
SponsorShanghai Pulmonary Hospital, Shanghai, China
Academic / other
Drugs / interventionschemotherapy, radiation
Locations14 sites (Hefei, Anhui and 13 other locations)
StatusRecruiting
StartedOctober 1, 2019
Main results expectedDecember 30, 2028
Study endsDecember 30, 2028
Registry record updatedApril 13, 2026
Trial IDNCT04937283 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
Show 8 more locations
  • 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
  • Email: dreamsuhang@163.com
  • Phone: +86 13917810850

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.