Comparison of Segmentectomy Versus Lobectomy for Early-stage Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field: A Prospective and Multi-center RCT Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Patient aged 18-75 years old;

• 6 mm ≤ tumor size ≤ 20 mm;

• 0.25 \< CTR \< 1;

• Center of tumor located in the middle third of the lung field;

• ECOG score of 0,1 or 2;

• Lung function (FEV1 ≥ 1 L and ≥ 70%);

• Both lung segmentectomy and lobectomy could achieve R0 resection;

• No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;

• No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;

⁃ Single tumor nodule or the concomitant nodule \< microinvasive tumor;

⁃ Written informed consent.

Locations
Other Locations
China
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Zhihua Li, M.D.
lizhihua_njmu@126.com
+86-025-68303743
Backup
Weibing Wu, M.D.
wuweibing95@163.com
+86-025-68303743
Time Frame
Start Date: 2021-07-20
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 1120
Treatments
Experimental: Segmentectomy
Patients receive segmentectomy
Active_comparator: Lobectomy
Patients receive lobectomy
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov